Available Clinical Trials for Pet Cancer Research

February 8th, 2012   •   no comments   

Updates: Available Clinical Trials for Pet Cancer Research

Part of the TVCR’s goal is to empower pet-owners with information. We know that pet-owners will go to great lengths to care for the health and well-being of their pet, but sometimes, they just don’t know where to start.

That’s why the TVCR has added a new feature to our site: a clinical trials listing.

As we grow and develop we will build out this searchable section to make it easier for pet-owners to access information about new and existing trials.

For more information on clinical trials, please see our listing.

 

GEORGIA

July 17th, 2013   •   no comments   

University of Georgia

For further information on any of the trials at UGA visit: http://vet.uga.edu/research/clinical/current or request additional information through the UGA Oncology service by calling the small animal referral coordinator at 706-542-5362.

Examining the efficacy of toceranib phosphate (Palladia®) as a primary and/or adjuvant agent in the treatment of feline oral squamous cell carcinoma

Study details:

Especies: cats

Tumor type: Oral Squamous Cell Carcinoma

Purpose of study: The objective of this study is to investigate the efficacy of toceranib phosphate (Palladia®) alone or as a radiation-sensitizing agent in the treatment of feline oral squamous cell carcinoma (SCC). Cats will receive Palladia® alone or in combination with palliative radiation therapy. Palladia® will be administered orally on a Monday/Wednesday/Friday schedule for up to one year. Radiation treatments will be delivered twice weekly for three weeks. Owners will elect which treatment the cat will receive: Palladia® alone or Palladia® and radiotherapy. Cats must have a confirmed diagnosis of oral SCC to be eligible for participation in this study.

Once accepted into the study, cats will have a physical examination and repeat laboratory blood work (CBC) performed weekly for the first 3 weeks, at week 5, and then at four-week intervals (week 9, 13, etc.) for up to one year. Palladia® will be provided at no charge to the client. Fees related to tumor staging, radiotherapy (if used), recheck visits, scheduled blood work and treatment of any side effects or unexpected complications are the financial responsibility of the owner.

 

Safety evaluation of an immunomodulator in cats as an adjunct treatment for fibrosarcoma under field conditions.

Study details:

Especies: cats

Tumor type: Fibrosarcoma

Purpose of study: Feline fibrosarcoma is well recognized in veterinary oncology. Although the reported metastatic rate is relatively low (0-28%), these tumors are extremely locally invasive, and recurrences are common despite aggressive local treatment. When treated with surgery alone, recurrence is likely despite apparent complete excision, and the median time to first recurrence is very short. Despite recent advancements in surgical, radiation, and medical therapies, control of this disease remains very challenging. The objectives of this study are to evaluate the safety of an immunomodulator in cats as an adjunct treatment for fibrosarcoma.

We expect this trial will provide valuable information about the safety of the immunomodulator in cats with fibrosarcoma.

 

The treatment of canine brain tumors with Cetuximab administered using convection enhanced delivery (CED)

Study details:

Especies: dogs

Tumor type: canine brain tumors

Purpose of study: Given their location within the skull, many brain cancers are not accessible to surgical excision, the main treatment option for brain cancer. Likewise, chemotherapy has traditionally been ineffective due to limited access allowed by the blood brain barrier. In an effort to deliver chemotherapy drugs directly into a cancer, a procedure called convention enhanced delivery (CED) has been developed. This procedure uses a small catheter placed into a cancer which allows delivery of a high dosage of chemotherapy directly into the cancer, thus limiting systemic drug concentrations a patient must receive and therefore minimizing chemotherapy side effects.

This study will evaluate infusion of a new drug (Bioconjugated Cetuximab Iron Oxide Nanoparticles; BCIONPs) directly into the brain tumor using CED. The drug Cetuximab has been used in the treatment of brain tumors in humans, and preliminary studies in healthy dogs has shown Cetuximab IONPs delivered using CED to be a safe treatment modality.

 

Phase I clinical trial of 5-fluorouracil in tumor-bearing dogs

Study details:

Especies: dogs

Tumor type: Epithelial tumors

Purpose of study: 5-fluoropyrimidime antimetabolite drugs such as 5-fluoruracil (5-FU) are primarily used in human oncology to treat epithelial tumors. Although 5-FU has been used to treat cancer in dogs, its dosage, treatment schedule, and toxicities have never been appropriately investigated. The objectives of this study are to determine the maximum tolerated dosage, to establish a safe starting dosage, and to determine treatment-related side effects of 5-FU in dogs with cancer. Dogs must have a confirmed diagnosis of malignant cancer to be eligible for participation in this study. Assuming the dog tolerates the first four treatments well, treatments may be continued, off study, at the owner’s expense. Up to $500 is budgeted per dog to treat severe complications of treatment (should they occur). Any costs greater than $500 will be the owner’s responsibility.

5-FU is an underutilized, yet relatively inexpensive chemotherapeutic drug; its use in veterinary medicine has been limited by its associated neurotoxicity. We expect this trial will provide valuable information about the safe dosage and toxicity of 5-FU in dogs with cancer, thereby supplying another option in our arsenal of canine cancer treatments.

 

Use of indocyanine green (ICG) and an intraoperative spectroscopy and imaging system (ISIS) in dogs with malignant solid tumors

Study details:

Especies: dogs

Tumor type: Any solid malignant tumor

Purpose of study: The purpose of this study is to investigate the use of a portable handheld imaging device (ISIS) to more accurately identify residual tumor cells within the walls of the surgical cavity. The ultimate goal is to improve detection of microscopic tumor boundaries during surgical excision. Dogs must have a biopsy confirmed diagnosis of malignant solid tumor to be eligible for participation in this study.

With the ability to better determine microscopic tumor extension intra-operatively, we may be able to reduce morbidity associated with tumor resection and improve the likelihood of complete tumor resection during the first surgical attempt. Furthermore, studies of this system in dogs with cancer will complement currently planned human trials designed to test similar endpoints.

 

Phase I/II clinical trial of canine parainfluenza virus (PIV5) as an anti-cancer agent in dogs

Study details:

Especies: dogs

Tumor type: Malignant solid tumors

Purpose of study: Use of oncolytic viruses as anti-tumor agents is a viable alternative to standard cancer therapies. Many viruses have demonstrated efficacy in killing cancer cells in vitro and in vivo; currently some are being tested in human clinical trials. In our preliminary studies, we determined that canine parainfluenza virus (PIV5) is effective in treating human breast cancer, human melanoma, and human lung cancer using mouse xenograft models. The objectives of this study are to determine the safety and potential efficacy of PIV5 therapy in dogs with cancer. Dogs must have a biopsy confirmed diagnosis of malignant solid tumor to be eligible for participation in this study.

This trial is expected to provide valuable information about the safety and efficacy of PIV5-based therapy as an alternative to current cancer treatments. We expect intratumoral administration of PIV5 will be safe, and we do not anticipate significant viral shedding from intratumorally treated dogs. If successful, this virus-based therapy can be incorporated into other cancer treatment protocols, in hopes of improving tumor control, extending survival times, and possibly improving quality of life. Alternatively, virus-based treatments can be used as a sole modality in cases where other treatments are not viable options.

 

Phase II evaluation of GS-9219 in canine cutaneous lymphoma

Study details:

Especies: dogs

Tumor type: Lymphoma

Purpose of study: The purpose of this study is to evaluate the efficacy of a new chemotherapy drug for canine cutaneous T cell lymphoma (CTCL). Lymphoma is one of the most common cancers diagnosed in dogs, and although most dogs with multicentric lymphoma initially respond well to chemotherapy, response rates are considerably lower in dogs with CTCL. GS-9219 is a novel drug that has demonstrated efficacy in dogs with multicentric lymphoma. For the most part, GS-9219 has been well tolerated in dogs, with potential side effects including bone marrow suppression, skin toxicity, and gastrointestinal upset. Dogs must have a histologically confirmed diagnosis of CTCL to be eligible for participation in this study. In addition the following conditions must be met:

Lymphoma is one of the most commonly diagnosed cancers in dogs. While conventional chemotherapy induces remission in the majority of dogs with multicentric lymphoma, novel treatments are needed for the cutaneous form of this disease. Successful demonstration of efficacy of GS-9219 against canine CTCL will provide an important drug in the veterinarian’s armamentarium against this challenging disease.

 

Examining the efficacy of toceranib phosphate (Palladia™) as a primary and/or adjuvant agent in the treatment of canine nasal carcinoma

Study details:

Especies: dogs

Tumor type: Canine nasal carcinoma

Purpose of study: The purpose of this study is to determine the activity of toceranib phosphate (Palladia™) alone or as a radiation sensitizing agent in the treatment of canine nasal carcinoma. Results from this study may provide a novel avenue of treatment for this type of cancer. Dogs must have a confirmed diagnosis of intranasal carcinomas to be eligible for participation in this study.

Currently radiation therapy is the treatment of choice and is the only modality which has resulted in improvement of survival times for dogs with nasal carcinoma. It is hoped that the radiation sensitizing effects of Palladia, in conjunction with radiation therapy, will prolong the time until cancer progression and extend survival times in these patients.

 

COTC018: Evaluation of iniparib in tumor bearing dogs to define its pharmacokinetic profile and biological activity

Study details:

Especies: dogs

Tumor type: Any cancer

Purpose of study: The purpose of this study is to evaluate the safety and efficacy of iniparib, a novel anticancer agent, in dogs with cancer. Iniparib has been safely evaluated in human patients with cancer and normal research dogs; however this agent has not been previously used in dogs with cancer either alone or in conjunction with carboplatin. Dogs must have a biopsy confirmed diagnosis of a malignant melanoma, head and neck carcinoma, or soft tissue sarcoma to be eligible for participation in this study.

It is hoped that dogs with tumors will show an improved response to this novel treatment. In addition, studies of this new drug in dogs with cancer will complement currently planned human trials designed to test new doses and effects of this agent.

 

Prospective comparative evaluation of canine lower urinary tract transitional cell carcinoma with magnetic resonance imaging and ultrasound

Study details:

Especies: dogs

Tumor type: Transitional Cell Carcinoma

Purpose of study: The purpose of this study is to evaluate the potential of magnetic resonance imaging (MRI) to accurately define the presence and extent of transitional cell carcinoma (TCC), as well as better defining metastatic disease (spread) to regional lymph nodes. Transitional cell carcinoma is currently a challenging cancer process to accurately characterize and monitor for response to different therapies. Ultrasound examination of the bladder, urethra and prostate is the most commonly used imaging test, but due to the inherent inadequacies of ultrasound, advanced imaging using modalities with better resolution for neoplastic processes needs to be investigated. MRI has proven superior in human patients with transitional cell carcinoma, but has not been examined in canine patients. Dogs must have confirmed diagnosis of lower urinary tract TCC to be eligible for participation in this study.

It is hoped that resulting data would provide evidence of the accuracy of MRI in evaluating TCC. The long term goal of this study is to prospectively and non-invasively monitor treatment response to

OHIO

July 17th, 2013   •   no comments   

Ohio State University

For further information on any of the clinical trials please visit: http://vet.osu.edu/vmc/clinical-trials OR contact

An Exploratory Study of the Oral Selective Inhibitor of Nuclear Export (SINE) KPT-335 in Dogs with Lymphoma

Study Details:

Especies: dogs

Tumor type: Lymphoma

Purpose of Study: The purpose of this study is to evaluate the safety and antitumor activity of KPT-335 in dogs with lymphoma, either newly diagnosed or in first relapse after completion of a single chemotherapy protocol (multi-agent or single agent).

A study of KPT-335 was performed in dogs with cancer and the dose of 1.5 mg/kg was found to be well-tolerated over 4-20 weeks of dosing when given on a Monday/Wednesday/Friday (MWF) basis.  In dogs with lymphoma, partial shrinkage of lymph nodes and stable disease were noted in over half of the patients treated.  Side effects from KPT-335 given at this dose on a MWF basis included mild loss of appetite, occasional vomiting, and diarrhea, with some dogs experiencing an increase in thirst and an increase in urination.  All of these side effect were mild and well-controlled with additional medications.

Palladia or Palladia plus Radiation Therapy in Cats with Oral Squamous Cell Carcinoma

Study Details:

Especies: cats

Tumor type: Oral Squamous Cell Carcinoma

Purpose of Study: The purpose of this study is to identify the activity of toceranib phosphate (Palladia) alone or as a radiation sensitizing agent in the treatment of feline oral squamous cell carcinoma. Inclusion Criteria:

  • Have histologically or cytologically confirmed diagnosis of oral SCC
  • Have a life expectancy of at least 6 weeks
  • Have no evidence of metastatic disease at the time of enrollment
  • Have no other serious health problems that are incompatible with the study (as renal, cardiac or hepatic insufficiency)

A Pilot Study of Vinblastine/Palladia Therapy for Canine Transitional Cell Carcinoma

Study Details:

Especies: dogs

Tumor type: Transitional Cell Carcinoma

Purpose of Study: The goal of this study is to assess efficacy of Palladia and Vinblastine combined for treatment of canine transitional cell carcinoma and to compare computerized tomography and ultrasound for measurement of tumor response.

The two drugs to be combined in this clinical trial are vinblastine, a chemotherapy agent used to treat several different cancers in dogs, and Palladia, an oral drug that works by blocking the signaling of several receptors, including VEGFR2 and PDGFR.  Both VEGFR2 and PDGFR are important in permitting the growth of new blood vessels, so Palladia works to slow down or block the growth a blood supply into tumors and prevent them from continuing to grow.  There is preliminary evidence that both vinblastine and Palladia may each have some activity against TCC in dogs.  A recent pilot study demonstrated that 36% of dogs with TCC given vinblastine had their tumor shrink partially following treatment and another 50% had their tumors stop growing for a period of time.  In previous work with Palladia, 3 of 4 dogs treated with drug had their tumors stop growing for a period of time.  Vinblastine and Palladia have recently been combined together in a clinical trial to determine how best to use these drugs together in the setting of mast cell cancer.  This study identified the dose of vinblastine and Palladia  that could be safely combined over multiple treatments.  These doses will be used in the current study.

Kit mutation and localization status as response predictors in canine mast cell tumors treated with toceranib or vinblastine: A multi-center response-adaptive randomized trial

Study Details:

Especies: dogs

Tumor type: Mast Cell Tumor

Purpose of Study: The goal of this study is to determine if canine mast cell tumors with kit mutation respond better to Palladia and whether screening for kit mutations play a role in treatment decision-making. Dogs with MCT will undergo screening including complete blood count, chemistry panel, urinalysis and abdominal ultrasound to determine eligibility for the study.  A baseline tumor biopsy will then be obtained if my dog is found to be eligible.  Following biopsy, your dog will receive Benadryl, prilosec, and prednisone for at least 72 hours prior to treatment with either vinblastine or Palladia.  The determination of treatment protocol will be made by study personnel at Colorado State University.  If your dog has been assigned to receive vinblastine, the drug will be administered by intravenous injection once per week for 4 weeks, then every other week for another 4 treatments (total of 8 treatments).  If your dog has been assigned to receive Palladia, the drug will be administered orally on Monday, Wednesday, and Friday every week for a total of 3 months.  If progressive disease is noted during the planned treatments, then your dog will be removed from the study and other therapies will be offered.  Dogs in either treatment arm will be evaluated weekly for the first 4 weeks, then every other week for the next 8 weeks.

Pulse Toceranib plus Lomustine for the Treatment of Unresectable Canine Mast Cell Tumors: A Multicenter Study Led by Colorado State University

Study Details:

Especies: dogs

Tumor type: Mast Cell Tumor

Purpose of Study: This study is a multi-center effort led by Dr. Doug Thamm at Colorado State University to determine the maximum tolerated dose, tolerability and adverse effect profile of combined treatment with pulse-dose toceranib and lomustine in dogs with MCT. He also would like to determine the response rate and progression-free interval in dogs with measurable MCT treated with combined pulse-dose toceranib and lomustine. If, upon evaluation, the dog meets eligibility criteria, the owner must complete an Owner Consent Form of their pet’s initial clinical appearance. For baseline status, blood and urine will be sampled; target tumors identified, measured. Also thoracic radiographs and/or abdominal ultrasound will be performed, as well as, tumor and skin biopsies.

 

COTC007b: Preclinical Comparison of Three Indenoisoquinolines Candidates in Tumor-Bearing Dogs

 Study Details:

Especies: dogs

Tumor type: Lymphoma

Purpose of Study: The purpose of this trial evaluating three structurally related chemotherapy drugs to to define their safety, pharmacokinetics, and pharmacodynamic modulation.

 

Evaluation of KUN C01 in dogs with spontaneous solid tumors

Study Details:

Especies: dogs

Tumor type: Mast Cell Tumor

Purpose of Study: The primary objective of this clinical trial is to evaluate the safety and tolerability of KUN C01 given to dogs with solid tumors (carcinomas, sarcomas, mast cell tumors, melanomas) and the secondary objective is to describe the antitumor response in tumor-bearing dogs.

Contact Information for this trial: Dr. Francisco Clemente Vicario Email: Phone 614-688-5713 or 614-247-870

TEXAS

July 17th, 2013   •   no comments   

Texas A&M University


Activated autologous T cell killing of CD 20+ B cell lymphoma in the Dog.

For further information on these trial contact: Heather Wilson, DVM, DACVIM (Oncology) 979-845-235 animalcancer@cvm.tamu.edu

Study details:

Species: Dogs

Tumor: Lymphoma

Purpose of Study: Any dog weighing over 35 lbs that has been diagnosed with B cell Lymphoma and is being treated with prednisone alone is eligible for this study.

 

Alteration of the intestinal microflora after chemotherapy in dogs.

Study details:

Species: Dogs

Tumor: Any cancer

Purpose of Study: dog must have a confirmed diagnosis of cancer and receive doxorubicin (a chemotherapy drug) as part of their treatment protocol. Two pretreatment fecal (stool) samples are needed and may be frozen before your first appointment.

We have also partnered with Sugarland Veterinary Specialists.

 

S100b inhibitors for the treatment of canine malignant melanoma

Study details:

Species: Dogs

Tumor: Melanoma

Purpose of Study: Inclusion Criteria and General Background Information: dog must have a confirmed diagnosis of melanoma and several tests to ensure his/her general health and to assess how advanced the disease is prior to treatment. The tumor will be biopsied prior to therapy. Tumors must be large enough to biopsy and your dog must have no other significant health problem. Your dog will receive one of two drugs or a combination of the two. Both drugs are FDA approved and have been used in dogs previously for other reasons. Interactions between these drugs and other drugs are unknown; therefore it is important to tell your veterinarian about any medications (and supplements) your dog is currently taking. It is strongly encouraged to eliminate all unnecessary medications. This should be discussed with your oncologist if you have any questions.

 

Radiation Therapy for dogs with multicentric lymphoma

For further information on this specific trial contact: Michael Deveau, MS, DVM, DAVR(Radiation Oncology) Clinic Phone: 979-845-2351, Email: animalcancer@cvm.tamu.edu

Study details:

Species: Dogs

Tumor: Lymphoma

Purpose of Study: Any dog weighing over 10 lbs that has been newly diagnosed with lymphoma. Dogs will receive full body imaging before therapy, then treated with chemotherapy for 19 weeks (stnadard therapy for canine lymphoma), after completion of chemotherapy dogs will receive 2 weeks (10 doses, M-F) of radiation therapy.

 

Evaluation of Iniparib in tumor-bearing dogs

Study details:

Species: Dogs

Tumor: melanoma, squamous cell carcinoma, soft tissue sarcoma or mammary carcinoma.

Purpose of Study: Any dog weighing over 21 lbs that has been diagnosed with melanoma, squamous cell carcinoma, soft tissue sarcoma or mammary carcinoma. Each dog will participate for 15-22 days in the study. There are two groups of dogs that will be enrolled. Group A will be dogs with any of the above tumor types and Group B is for dogs with mammary carcinoma only.

 

Evaluation of new renal (kidney) biomarkers for kidney damage in normal dogs and dogs receiving nephrotoxic drugs.

Study details:

Species: Dogs

Tumor: Kidney disease

Purpose of Study: Inclusion Criteria and General Background Information: Dogs receiving kidney toxic drugs (e.g., tyrosine kinase inhibitors): must be at least 2 years old, must weigh at least 22 lbs, must have no previous history of kidney disease or protein in the urine, must have a life expectancy of at least 4 months. Dogs receiving Kidney toxic drugs (e.g., tyrosine kinase inhibitors) will participate for up to 6 months with a pretreatment blood and urine sample, and additional samples two weeks after initiation of therapy and then monthly thereafter.

INDIANA

July 17th, 2013   •   no comments   

Purdue University

For more information on any of the clinical trials at Purdue University contact Ms. Patty Bonney, RVT, at (765) 494-1130 or (765) 494-1107, or contact Dr. Christopher Fulkerson at (765) 494-1107 OR visit “http://www.vet.purdue.edu/pcop/pcop-clinical-trials.php“

Zebularine (“Zeb”) Treatment of TCC in Dogs

Study details: Canine urinary bladder cancer

Species: Dogs

Tumor: Bladder cancer

Purpose of Study: Zeb is an oral medicine in a new category of cancer drugs called demethylating agents. Demethylating agents work differently than traditional cancer drugs. Traditional cancer drugs stop DNA replication or block cancer cell division by similar means. Demethylating agents reactivate genes within the cancer cells called tumor suppressor genes. In humans and dogs that do not have cancer, tumor suppressor genes are working to prevent cancer from forming and growing. In dogs and humans that do have cancer, however, the tumor suppressor genes are not working correctly. An important mechanism that keeps these genes from working properly is through the attachment of methyl groups to a specific part of the gene. Zeb and similar drugs remove the methyl groups or prevent methyl groups from attaching, thereby allowing the tumor suppressor genes to return to their normal function, i.e. stopping cancer. Zeb has been very well tolerated with few side effects at the doses being used in dogs. There are two components to this study: (1) to determine how well zeb works by itself, and (2) to determine the beneficial effects of zeb given with a traditional chemotherapy drug called carboplatin.

Folate-targeted Therapy ( EC0531, Folate-tubulysin) to Treat TCC in Dogs

Study details: Folate targeted therapy

Species: Dogs

Tumor: Bladder or urethra tumors

Purpose of Study: Dr. Low’s laboratory made an important discovery a few years ago that certain cancers in humans and animals take up much more of the vitamin folate than normal cells, sometimes 100 times more. This provides the opportunity to attach cancer treatment agents to folate in order to selectively “deliver” the cancer drugs to the cancer cells with much less exposure to normal cells. This is expected to allow more effective treatment of the cancer while having less risk of side effects. Folate-targeted therapy is already showing promise in clinical trials in humans with ovarian and lung cancer, but has not yet been studied in humans with bladder cancer. A study has already been completed at Purdue showing that folate attached to the chemotherapy drug vinblastine has good antitumor activity against TCC in dogs, and that the drug can be given safely. The new clinical trial for dogs will include a different folate-drug conjugate, folate attached to a cancer drug called tubulysin. Based on work in cell culture and work in laboratory animals, folate-tubulysin is expected to be even more effective than folate-vinblastine. It is important to note that the folate uptake in the cancer varies from dog to dog, and tests must be done to determine if an individual dog’s tumor takes up the folate. One of the tests to detect folate uptake is a folate scan in which a folate imaging agent is given to the dog, and 2 hours later images of the dog made with a special “x-ray” machine called a gamma camera. The other test is performed on tumor tissue from the dog. If the cancer takes up folate, then it is likely the dog could benefit from folate-targeted therapy, and participation in the study could be considered. If the cancer does not take up folate, then it would be better to pursue different therapy for that particular dog.

Study of the Causes and Outcome of TCC in Dogs

Study details: Folate targeted therapy

Species: Dogs

Tumor: Bladder or urethra tumors

Purpose of Study: Work is ongoing on several fronts to gain a better understanding of how TCC forms, what makes it respond to therapy or not, and what makes it progress. Veterinarians at Purdue are working diligently in this field, and have also teamed up with multiple scientists on campus and across the country to do molecular analyses to address these critical questions. In order to accomplish this work, it would be extremely helpful to obtain samples of blood, urine, and tumor tissue from dogs with TCC, and to be allowed to perform necropsies on dogs with TCC if they are to be euthanized due to declining quality of life related to the cancer or other conditions. This applies to dogs who are already patients of the Purdue University Veterinary Teaching Hospital and to other dogs that have not yet been to the Teaching Hospital, but which have confirmed or presumptive TCC.

Samples from dogs of any breed are very helpful. In addition to the work being done in dogs of any breed, dogs from breeds that have a higher risk of TCC (Scottish Terriers, West Highland White Terriers, Shetland Sheepdogs, Beagles) are also needed for a collaborative study with Dr. Elaine Ostrander at the National Institutes of Health. Work in these high risk breeds is defining underlying genetic factors that increase TCC risk, and that could lead to strategies to prevent TCC, or to find it earlier and treat it more effectively. Samples from dogs that already have TCC and samples from older dogs in high risk breeds that do not have cancer are needed.

CHOP vs. CHO Chemotherapy for Canine Multicentric Lymphoma

Study details: CHOP vs. CHO chemotherapy

Species: Dogs

Tumor: lymphomas

Purpose of Study: Combination chemotherapy with cyclophosphamide, doxorubicin, vincristine, and prednisone (“CHOP”) is considered the standard of care for canine intermediate-to-high grade multicentric lymphoma. Previous therapy with prednisone is known to decrease remission duration and survival time for dogs with CHOP-treated lymphoma, likely by increasing chemotherapy drug resistance within tumor cells. It is unknown whether removal of prednisone from the CHOP protocol affects drug resistance. In this study, dogs will be randomly assigned to CHOP or CHO (CHOP without prednisone) chemotherapy protocols, and remission rate, remission duration, and survival time will be compared between treatment groups.

Clinical Trial to Determine Activity of MLN0415 in Dogs with High-grade Multicentric Lymphomas

Study details: Oral chemotherapy with MLN0415

Species: Dogs

Tumor: lymphomas

Purpose of Study: This study involves the use of a new oral chemotherapy agent (MLN0415) for the treatment of canine lymphomas. MLN0415 inhibits a protein known as IKK; this protein is known to contribute to cancer progression and drug resistance in human lymphomas, and the same is suspected in canine lymphomas. This is a pilot study to determine whether MLN0415 has activity against untreated or relapsed canine multicentric lymphomas. MLN0415 will be administered orally twice daily and dogs will be rechecked at Purdue at weekly intervals.

Clinical Trial to Determine Activity of Carboplatin as a Rescue Chemotherapy Agent for Dogs with High-grade Multicentric Lymphomas

Study details: Carboplatin as a rescue chemotherapy

Species: Dogs

Tumor: lymphomas

Purpose of Study: Rescue chemotherapy is administered to dogs with lymphomas whose cancer has progressed in the face of first-line chemotherapy treatment. Rescue chemotherapy protocols are often expensive, and drugs used in these protocols have recently been subject to nationwide shortages. Carboplatin is commonly administered to dogs with a variety of cancers, and is well tolerated, relatively inexpensive, and readily available. The activity of carboplatin against canine lymphoma, however, has not been fully evaluated. This study is designed to determine the activity of single agent carboplatin in dogs with relapsed multicentric lymphoma. Dogs will be treated at Purdue with intravenous carboplatin once every 3 weeks.

COTC007b: Preclinical Comparison of Three Indenoisoquinolines Candidates in Tumor-bearing Dogs

Study details: Three Indenoisoquinolines in Tumor bearing dogs

Species: Dogs

Tumor: lymphomas

Purpose of Study: This is a multi-institutional trial administered through a division of the National Cancer Institute. Purdue is one of a group of veterinary schools (collectively known as the Comparative Oncology Trials Consortium, or COTC) enrolling dogs in this clinical trial. The trial is designed to determine the pharmacokinetics, maximally tolerated dose, and anti-tumor activity of three new chemotherapy agents in dogs with lymphoma. Data from this trial will be used to design similar, follow-up trials in human cancer patients. Dogs enrolled in this study will be boarded at the Purdue for 7 days, and will receive chemotherapy treatment on 5 consecutive days within this span. Dogs whose cancers respond to chemotherapy will be eligible for additional treatments given for 5 consecutive days, once every 3 weeks.

MICHIGAN

July 17th, 2013   •   no comments   

Michigan State University

Evaluation of intrinsic and acquired chemoresistance in canine histiocytic sarcoma.

Study Details: Evaluation of intrinsic and acquired chemoresistance in canine histiocytic sarcoma.

Species: Canines

Tumor: Histiocytic Sarcoma

Purpose of study: Canine histiocytic sarcoma is an aggressive form of cancer with a uniformly fatal outcome.  The disease affects primarily Bernese Mountain Dogs, Flat-Coated Retrievers, and Rottweilers.  Despite rigorous efforts to identify genetic abnormalities underlying this disease, little advance has been made with regard to treatment. In our study, we focus on gene expression patterns associated with resistance to chemotherapy.  We intend to develop a practical assay to guide future drug development for the treatment of canine histiocytic sarcoma.

If you are interested in participating in this study or would like additional study information, please contact Dr. Nikolaos Dervisis at 517-432-4700.

COLORADO

July 17th, 2013   •   no comments   

Colorado State University

For further information regarding all oncology trials at CSU please complete an online consult request form or call our Oncology Clinical Coordinator at (970) 297-4068.

Canine Various Tumor Types

Study Details:  Effect of Carboplatin on Circulating Endothelial Cells in Dogs with Cancer.

Species: Canines

Tumor: Various tumor types (except hemangiosarcoma).

Purpose of study: Chemotherapy typically is administered at maximally tolerated (high) doses at regular intervals, such as once every three weeks. Although the chemotherapy drug kills rapidly growing cancer cells, some normal cells (such as those in the bone marrow and intestines) are also affected and a recovery period is needed for these tissues to renew themselves. Unfortunately, this gap in treatment can allow the cancer cells time to grow as well. Research in mice and people has also shown that high-dose chemotherapy may also stimulate production of cells such as circulating endothelial cells (CECs) that likely help tumors develop a new blood supply (this process is called “angiogenesis”) and lead to further growth of the tumor. The effect of high-dose chemotherapy on CECs has not been previously evaluated in dogs. This study is being performed to determine the effect of standard doses of carboplatin chemotherapy on CECs in dogs with cancer.

 

Incorporation of PET/CT into Radiation Therapy Planning for Canine Nasal Tumors

Study Details:  Incorporation of PET/CT into Radiation Therapy Planning for Canine Nasal Tumors.

Species: Canines

Tumor: Nasal tumors

Purpose of study: Nasal tumors are common in dogs and most effectively treated with radiation therapy. Unfortunately, recurrence rate of nasal tumors unfortunately remains high even with the most current radiotherapy and imaging techniques. The use of PET/CT for radiation treatment planning has greatly improved treatment of human head and neck cancers but this technology has not been widely used in pets with cancers, including nasal tumors. PET stands for Positron Emission Tomography, which uses a radioactively labeled glucose tracer to image and measure the most aggressive areas of a tumor based on its metabolism, whereas more traditional CT imaging allows you to only visualize the anatomy. PET/CT is completely new to veterinary medicine and we expect it to provide valuable information that can improve our diagnosis and treatment of veterinary cancer patients.  We will then compare the results from the two types of scans (PET/CT versus CT scan) to determine which most accurately defines tumor margins and ultimately results in the most effective treatment of the disease.

As part of this clinical trial, your pet will receive a PET/CT scan under general anesthesia for further diagnostic information and radiation planning for treatment of his/her nasal tumor. Your pet will recover from anesthesia in the nuclear medicine ward and stay there for several hours after the procedure while the radioactive glucose tracer fades away. Participation in the clinical trial is complete once the PET/CT has been performed. Your pet may benefit directly from having a PET/CT scan if this new type of scan allows us to identify additional areas of tumor that should be treated.

 

Canine Mast Cell Tumors

Study Details:  Palladia vs. Vinblastine in Canine Mast Cell Tumors

Species: Canines

Tumor: Mast cell tumors

Purpose of study: Mast cell tumor is a common skin tumor of dogs. Current treatment options available for mast cell tumor include various combinations of surgery, chemotherapy drugs such as vinblastine or lomustine, radiation therapy, and the new oral mast cell tumor drug Palladia® (toceranib). Vinblastine is an intravenous chemotherapy agent that is commonly used in the treatment of mast cell tumors. Palladia is an oral drug that works by inhibiting the function of a protein important for mast cell survival called KIT. Activating mutations in KIT are found in a population of mast cell tumors, and Palladia has been shown to be more effective against tumors with this mutation. Through this clinical trial, we are seeking to investigate the difference in responses of mast cell tumors with and without a mutation in KIT to Palladia and vinblastine.

Treatment of Mast Cell Tumors with Palladia and CCNU

Study Details:  Treatment of Mast Cell Tumors with Palladia and CCNU

Species: Canines

Tumor: Mast cell tumors

Purpose of study: Mast cells are found in tissues throughout the body, and mast cell tumors are the most common skin tumor in dogs. Treatment for mast cell tumors may involve surgery, radiation therapy, and/or chemotherapy. CCNU (also known as lomustine) is a chemotherapy drug that has been used in the treatment of mast cell tumors in dogs. Palladia is the first veterinary anti-cancer drug. It acts to stop the effects of an enzyme involved in the growth of cancer cells. Palladia has been used in other clinical trials to treat dogs with mast cell tumors, sarcomas, carcinomas and melanoma. The purpose of this study is to determine if using Palladia in combination with CCNU will have better anti-tumor effect for dogs with mast cell tumors than CCNU used as a sole treatment.

 

Canine Soft Tissue Sarcomas

Study Details:  PET-CT Imaging of Canine Tumors with 64-Copper-ATSM to Detect Areas of Low Tumor Oxygen Level

Species: Canines

Tumor: Soft tissue Sarcoma

Purpose of study:  Tumors with areas of low oxygen level are more resistant to treatment by either radiation or chemotherapy. Those areas may also harbor primitive tumor stem cells that can cause a tumor to recur after therapy. The primary objective of this study is to perform and validate a new noninvasive diagnostic imaging method for imaging areas of a tumor with low oxygen, called a PET/CT scan. PET stands for Positron Emission Tomography, which will use a radioactively labeled tracer (64Copper-ATSM) that localizes to those areas of a tumor with low oxygen. CT is computed tomography, which allows us to visualize the anatomy. After PET/CT imaging, we will then obtain a biopsy specimen of that same area to study the characteristics of that tumor region. This information will contribute to the development of new and better ways to identify resistant tumor regions and treat those areas more appropriately, with the ultimate goal being to improve cancer treatment. The PET/CT scan may also help us better stage your pet’s cancer by looking for potential areas of metastasis (spread of cancer).

 

Canine Lymphoma

Study Details:  Hydroxychloroquine to Enhance Doxorubicin Effectiveness

Species: Canines

Tumor: any measurable cancer disease

Purpose of study:  This clinical trial is designed to evaluate a form of treatment for dogs with cancer using a combination of the antimalarial drug hydroxychloroquine (HCQ) and the chemotherapy agent doxorubicin (DOX). Recent studies suggest that HCQ can sensitize human tumor cells to the anti-cancer effect of DOX. Recent studies in dogs with skin disease have demonstrated that long-term HCQ treatment appears to be well-tolerated.  The combination of these two treatments has not been explored in canine cancer patients. The goal of this study is to determine the maximum tolerated dose of HCQ that can be administered to tumor-bearing dogs when followed by a standard dose of DOX.

 

Monoclonal Antibody Therapy of Canine B-cell Lymphoma

Study Details:  Monoclonal Antibody Therapy of Canine B-cell Lymphoma

Species: Canines

Tumor: Lymphoma

Purpose of the Study: We are investigating whether an antibody that specifically targets a particular receptor on the surface of malignant B cells could be used to treat dogs with B cell (non-Hodgkin’s) lymphoma. Many types of lymphoma have this receptor on their surface at high levels, a property that makes them stand out from normal immune cells in the body. An antibody targeting this receptor (known as IMMU-114) has recently been developed and is being investigated as a possible new treatment for both humans and dogs with B cell lymphoma. We have tested this antibody in normal, healthy dogs and found that it is safe as long as it is given slowly as an intravenous infusion during an overnight hospital stay. We are now ready to begin evaluating the antibody in dogs with lymphoma so that we evaluate its potential efficacy in treating this common disease.

 

Phase-II Evaluation of GS-9219 in Canine Cutaneous Lymphoma

Study Details:  Phase-II Evaluation of GS-9219 in Canine Cutaneous Lymphoma

Species: Canines

Tumor: Lymphoma

Purpose of the Study: Canine cutaneous lymphoma is an uncommon but uniformly fatal canine disease. While most dogs may respond to treatment with chemotherapy, responses can be variable and are generally short in duration. New treatments for this disease are needed to improve patient comfort and survival. We previously demonstrated that a novel cancer drug GS-9219 is effective against multicentric lymphoma in dogs. One of the observed toxicities with this drug was a skin change characterized by hair loss, redness and itching, implying significant delivery of GS-9219 to the skin. Given the lack of durable effective therapy for canine cutaneous lymphoma, and the demonstrated anti-lymphoma activity and apparent skin accumulation of GS-9219, we hypothesize that GS-9219 may be an effective drug against canine cutaneous lymphoma.

 

Preclinical Comparison of Three Indenoisoquinolines Candidates in Tumor-Bearing Dogs

Study Details:  Preclinical Comparison of Three Indenoisoquinolines Candidates in Tumor-Bearing Dogs

Species: Canines

Tumor: Lymphoma

Purpose of the Study: This clinical trial sponsored by the National Cancer Institute (NCI) assesses the safety and effectiveness of three newly developed chemotherapy agents (indenoisoquinolines) when given to dogs with lymphoma. Although this class of compounds has shown efficacy in a variety of cancers, interest in developing new topoisomerase I inhibitors, indenoisoquinolines, are currently being evaluated in human patients as agents with improved drug stability and measurable blood levels. This study will be the first time the indenoisoquinolines are being assessed in dogs with cancer. This trial is divided into 2 phases of which enrolled dogs will be involved in one. It includes a dose finding phase for safety and a validation phase for biological assay development (tumor marker evaluation pre and post treatment). Anti-cancer activity against canine lymphoma will be assessed in both phases.

LOUISIANA

July 17th, 2013   •   no comments   

Louisiana State University

Canine Osteosarcoma Study

Study Details: Canine Osteosarcoma Study

Species: Canines

Tumor: Osteosarcoma

Purpose of study: In this study, dogs diagnosed with osteosarcoma are invited to participate. The participant patient will be treated with amputation, IL-12 and standard chemotherapy treatment. IL-12 administration via electroporation will be performed 2-7 days prior to and 2-7 days post surgery. If you are not satisfied with the outcome, you can withdraw your pet from the clinical trial anytime. The participant patients will be anesthetized through LSU-SVM anesthesia service for performing the treatment, including injection of the immune stimulator via electroporation. Needles will be inserted into tumors for injection and electroporation. The electroporation lasts for less than one second and the whole procedure last for less than 5 minutes once dogs are under anesthesia. A total of two IL-12 administrations via electroporation will be performed. Prior to both the first and the second IL-12 administration, blood will be drawn for CBC, serum chemistry profile, and cytokine profile analysis. A follow-up check will be performed one week after the second treatment. Carboplatin (a standard chemotherapy drug) will be administered every 3 weeks, and a total of five doses will be administered. A follow-up recheck will be performed every other month after completion of the chemotherapy protocol.

For further information on this study contact: Dr Keijiro Shiomitsu (225) 578-9600 Fax: (225) 578-9559 E-mail: or Dr Tracy Gieger Phone: (225) 578-9600 Fax: (225) 578-9559 E-mail:

 

NEW YORK

July 17th, 2013   •   no comments   

Cornell University

 

CLINICAL TRIALS FOR CATS

DNA damage response mechanisms and chemosensitivity of feline injection site sarcomas

Study Details: DNA damage response mechanisms and chemosensitivity of feline injection site sarcomas

Species: Felines

Tumor: Sarcomas

Purpose of study: Determine whether alterations in DNA damage response mechanisms impact whether or not a given tumor is susceptible to chemotherapy. This study involves collection of tumor biopsies and in vitro laboratory analysis of those biopsies.

For additional information, please contact Dr. Kelly Hume or Dr. Cheryl Balkman of the Cornell University Hospital for Animals Oncology Service at 607-253-3060.

Individualized dosing of carboplatin in cats with injection site sarcomas

Study Details: Individualized dosing of carboplatin in cats with injection site sarcomas

Species: Felines

Tumor: Sarcomas

Purpose of study: Determine the response rate and toxicity of carboplatin treatment (dosage based on GFR) in cats with injection site sarcomas. It is hypothesized that individualized dosing of carboplatin based on kidney function will be effective and well tolerated.

For additional information, please contact Dr. Kelly Hume or Dr. Cheryl Balkman of the Cornell University Hospital for Animals Oncology Service at 607-253-3060.


 

CLINICIAL TRIALS FOR DOGS

A pilot study to determine if Palladia™induces hypothyroidism in dogs

Study Details: A pilot study to determine if Palladia™induces hypothyroidism in dogs.

Species: Canines

Tumor: Thyroid carcinoma

Purpose of study: To determine whether Palladia induces hypothyroidism in dogs and to assess the mechanism of this phenomenon.

For additional information, please contact Dr. Vanessa Rizzo, Dr. Kelly Hume, or Dr. Cheryl Balkman of the Cornell University Hospital for Animals Oncology Service at 607-253-3060.

ILLINOIS

July 16th, 2013   •   no comments   

Illinois University

Phase I trial- Development of bone-seeking nanoparticles encapsulating doxorubicin for canine appendicular osteosarcoma

Study Details:

Species: canine

Tumor: Appendicular Osteosarcoma

For more information visit: http://vetmed.illinois.edu/vth/documents/clinical_trials/MAFNanoparticlerialAnnouncement2009FINALVersion.pdf

Purpose of the study: Osteosarcoma is the most common bone tumor affecting the dog, with approximately 8,000 new cases diagnosed annually. Conventional therapies for managing osteosarcoma include amputation of the affected limb with concurrent administration of chemotherapy. For dogs not suitable for amputation, controlling bone tumor pain remains of utmost importance. Although palliative radiation therapy and intravenous aminobisphosphonates provide some analgesia, their duration of effect is short-lived. As such, there remains the need for discovering newer and better localized therapies which will ultimately improve quality of life for dogs diagnosed with appendicular osteosarcoma.
Encouragingly, bone-seeking nanoparticles may provide a new way to locally deliver high concentrations of anticancer agents directly to the bone tumor microenvironment, while sparing the systemic organs from conventional toxicity. As such, it is hoped that bone-seeking nanoparticles will eventually have a definitive role for improving treatments in dogs with osteosarcoma. The first phase of this study is to characterize the local biodistribution and to identify a safe dosage of bone-seeking nanoparticles encapsulating doxorubicin in osteosarcoma-bearing dogs. This will be achieved by treating dogs with a single dosage of bone-seeking nanoparticle encapsulating doxorubicin, and evaluating biologic effects as determined by appropriate surrogate markers.

WISCONSIN

July 16th, 2013   •   no comments   

UW-Madison

For additional information regarding any of these oncology studies, please contact Dr. Kathleen Tsimbas or members of the Oncology Service at (608) 263-7600. OR http://uwveterinarycare.wisc.edu/clinical-trials/oncology/

TREATMENTS STUDIES FOR SPECIFIC CANCER TYPES

Lymphoma: Newly Diagnosed or Recurrent

Study Details: This clinical trial sponsored by the National Cancer Institute (NCI) assesses the safety and effectiveness of three newly developed chemotherapy agents (indenoisoquinolines) when given to dogs with lymphoma. Studies in mice and non-tumor-bearing dogs have shown indenoisoquinolines to be safe.

Especie: dogs

Tumor type: Lymphoma

Purpose of study: The study involves intravenous administration of an indenoisoquinoline daily for 5 consecutive days. Blood samples, bone marrow biopsies, and tumor biopsies will be collected prior to treatment and following the first and fifth treatment. The first week of this study will necessitate a minimum of 2 nights, if not all, overnight boarding at the Hospital. Dogs will then return weekly for reevaluation and subsequent blood collection (Day 8, 15, 22 and 29). Continuance on study beyond day 29 will be based on response to indenoisoquinoline therapy. Costs associated with this study will be provided by the study. In the event any complications arise during the study period, their management will be covered by study funds up to $2,000/per dog/per event. This would include any unanticipated hospitalizations. In addition, a gift of $1,000 (one thousand dollars) will be credited to the owner’s UW Veterinary Care account.

Lymphoma of the skin (Cutaneous T Cell Lymphoma)

Study Details: Treatment trial for lymphoma of the skin

Especie: dogs

Tumor type: Lymphoma

Purpose of study: The most common type of lymphoma in dogs is multicentric, meaning it involves several lymph nodes. A less common type of lymphoma, called cutaneous T cell lymphoma (CTCL), presents as tumors in the skin. While dogs with multicentric lymphoma initially respond to currently available chemotherapy protocols, response rates are considerably lower and generally briefer in duration in patients with CTCL. We previously demonstrated the effectiveness of the novel chemotherapy agent GS-9219 in dogs with multicentric lymphoma in which 100% of newly diagnosed dogs and 60% of previously treated (with chemotherapy drugs other than GS-9219) dogs experienced anti-tumor responses. One of the observed side effects in GS-9219-treated dogs was a skin reaction characterized by redness, hair loss, and itching, implying significant delivery of GS-9219 to the skin. Given the lack of effective therapy for canine CTCL and the demonstrated anti-lymphoma activity and apparent skin accumulation of GS-9219, we are evaluating the effectiveness of GS-9219 in canine CTCL. GS-9219 will be administered as a 30-minute intravenous infusion once every 21 days.

Mast Cell Tumors

Study Details: Mast cell tumors (MCT) are a common skin tumor of dogs. Current treatment options available for MCT include various combinations of surgery, chemotherapy drugs such as vinblastine or lomustine, radiation therapy, and the new oral MCT drug Palladia® (toceranib). We currently have two clinical trials for dogs with MCT:

Especie: dogs

Tumor type: Mast cell tumors

Purpose of study: In the first trial, we are seeking to investigate the difference in responses of MCT with and without a mutation in KIT to Palladia and vinblastine. Vinblastine is an intravenous chemotherapy agent that is commonly used in the treatment of MCT. Palladia is an oral drug that works by inhibiting the function of a protein important for mast cell survival called KIT. Activating mutations in KIT are found in a population of MCT, and Palladia has been shown to be more effective against tumors with this mutation. Dogs with confirmed MCT, with or without lymph node involvement, may be eligible for this study. Prior surgery for MCT is acceptable, but no previous medical therapy (steroids, chemotherapy, etc.) is permitted. Upon entry, dogs will be randomized to receive either Palladia or vinblastine. The study will pay for the initial biopsy, KIT genotyping (to determine mutation status), chemistry profiles, and costs associated with treatment (Palladia or vinblastine). The owner will be responsible for the costs of the initial examination and tests to insure eligibility to participate (approximately $400), the recheck examinations, complete blood counts, and ancillary medications (diphenhydramine, omeprazole, prednisone).

In the second trial, we are investigating the combination of Palladia and lomustine. Dogs with confirmed MCT, with or without lymph node involvement, may be eligible for this study. Prior surgery and chemotherapy for MCT is acceptable with the exception of prior treatment with Palladia or lomustine. Dogs that have received Palladia or lomustine are not eligible for this study. All dogs will receive Palladia and lomustine. The dose of lomustine will be increased as dogs are entered into this trial so that we can determine the maximum tolerated dose of lomustine when given in combination with Palladia. The study will pay for the costs associated with treatment (Palladia and lomustine), and physical examinations and blood tests required throughout treatment. The owner will be responsible for the costs of the initial examination and tests to insure eligibility to participate (approximately $400) and ancillary medications (diphenhydramine, omeprazole, prednisone).

Nasal Tumors

Study Details: Tomotherapy dose painting clinical trial for dogs with nasal tumors of adenocarcinoma histology:  Conformal avoidance of eyes and brain with increase dose to regions of tumor hypoxia.

Especie: dogs

Tumor type: Nasal tumors

Purpose of study: Helical TomoTherapy™ is a combination of a linear accelerator and a helical CT scanner that delivers highly precise radiation to treat tumors while avoiding critical normal tissues. This radiation therapy machine was developed at the University of Wisconsin. In a previous study the UW-SVM treated 31 dogs with nasal tumors delivering dose to the tumor while avoiding the eyes, which significantly reduced ocular toxicity. In this new study we are evaluating molecular imaging of the tumor to guide and individualize each dog’s treatment plan with the goal to prolonging overall survival. Owners are responsible for the cost of the initial staging (approximate cost $1000-1200). Owners will pay $1500 toward this state-of-the-art therapy (typical cost is $4500-5000) and owners will pay for medications.
The study will pay for the following:

Dogs With a Malignant Mammary Tumor, Melanoma, Head and Neck Carcinoma, or Soft Tissue Sarcoma

Study Details: Safety of chemotherapy with Iniparib

Especie: dogs

Tumor type: Malignant mammary tumor, melanoma, head and neck carcinoma or soft tissue carcinoma.

Purpose of study: to assess the safety and effectiveness of iniparib, a novel anticancer agent, in combination with one dose of carboplatin, when given to dogs with cancer. Iniparib has been safely evaluated in human patients with cancer and in normal, non-tumor-bearing dogs. Carboplatin is a commonly used chemotherapy drug for the treatment of cancer in dogs.

Dogs that have been diagnosed with a new or recurrent malignant mammary tumor, melanoma, head and neck carcinoma, or soft tissue sarcoma may be eligible for this study. Dogs will be excluded from this study if they have had any prior therapy for their cancer other than surgery. The study involves four intravenous administrations of iniparib over the course of 22 days and one intravenous administration of chemotherapy (carboplatin) study day 8. Tumor biopsies will be performed prior to starting treatment and then once following each iniparib treatment.

 

TREATMENT STUDIES FOR ANY CANCER TYPE

Any Malignant Tumor in Dogs

Study Details: Doxorubicin trial

Especie: dogs

Tumor type: Any malignant tumor

Purpose of study: Doxorubicin is an effective chemotherapy drug commonly used for the treatment of various cancers in dogs including lymphoma, hemangiosarcoma, and osteosarcoma. The lifetime dose of doxorubicin is limited due to its cardiac toxicity, which limits the long-term use of this drug. Doxil®, a doxorubicin containing liposome, has been shown to decrease cardiac toxicity, prolong drug circulation times, and enhance anticancer effects (when compared to free doxorubicin). However, unlike free doxorubicin, a skin reaction (ranging from mild redness and hair loss to severe crusting, ulceration, and peeling of the skin) termed Palmar-Plantar Erythrodysesthesia Syndrome (PPES) or hand-foot syndrome can be dose-limiting for Doxil® in both dogs and people and often prevents repeated dosing. A new formulation of a doxorubicin containing liposome, called PLDMS, has been found to have increased anticancer activity and a reduced incidence of PPES when compared to Doxil®. The purpose of this study is to determine the maximum tolerated dose in dogs and compare the incidence of PPES to dogs in a previous study that had received Doxil®.

Any Malignant Tumor Other Than Mast Cell Tumor in Dogs

Study Details: Safety, efficacy and dosage of CCNU in combination with toceranib

Especie: dogs

Tumor type: All but Mast Cell Tumors

Purpose of study: The purpose of this study is to determine the safety, efficacy, and maximum tolerated dose of CCNU (lomustine) when given in combination with toceranib (Palladia) in tumor-bearing dogs (other than mast cell tumors). Prior surgery and chemotherapy is acceptable with the exception of prior treatment with toceranib or CCNU. Dogs that have received toceranib or CCNU are not eligible for this study. All dogs will receive toceranib, CCNU, and denamarin (a drug which protects the liver from potential side effects that have been associated with CCNU). The dose of CCNU will be increased as dogs are entered into this trial so that we can determine the maximum tolerated dose of CCNU when given in combination with toceranib.

 

STUDIES EVALUATING CHEMOTHERAPY SIDE EFFECTS

Incidence of bacterial infections in febrile and afebrile neutropenic patients undergoing chemotherapy

Study Details:

Especie: dogs

Tumor type: Any

Purpose of study: The purpose is to evaluate the culture isolates from neutropenic febrile and non-febrile canine chemotherapy patients.

Following owner consent for enrollment in the study, we will collect blood culture and sensitivity samples (aerobic and anaerobic) from two separate sites and a urine sample for complete urinalysis and urine culture and sensitivity. We will be using ultrasound-guidance to obtain urine via cystocentesis; when there is a contraindication to cystocentesis (thrombocytopenia or previously diagnosed urinary bladder neoplasia), we will collect a midstream voided urine sample.

Please contact Dr. Jonathan Bach if you have any questions about the study or study enrollment 608-263-7600.

 

IMAGING OR BIOPSY STUDIES

Any Malignant Tumor in Dogs

Study Details:

Especie: dogs

Tumor type: Dogs with any metastatic malignant tumor

Purpose of study: Computerized tomography (CT) is a commonly used diagnostic tool that provides information regarding the presence of tumors often too small to detect using conventional X-rays. Contrast agents that preferentially bind to tumors are often administered just prior to a CT scan to further enhance the chance of detecting a tumor. One of the limitations of currently used contrast agents is their short half-life, disappearing from the body within hours of administration. A contrast agent that remains in the body longer (for several days without adverse effects) would allow for the performance of multiple CT scans over time, which could provide valuable information regarding the effectiveness of anticancer treatments. The purpose of this study is to evaluate a novel imaging agent that has a half-life of at least 24 hours, allowing for the performance of multiple CT scans over time following a single injection, and has been found to provide greater resolution of the CT images which may increase the ability to detect tumors at an earlier stage of development. This is extremely important with regard to the ability to detect metastatic lesions in patients diagnosed with cancer and for the evaluation of the effect of their cancer treatment.

For additional information regarding any of these oncology studies, please contact Dr. Kathleen Tsimbas or members of the Oncology Service at (608) 263-7600.

Page 1 of 212»