Clinical Trials for Melanoma
Exploratory safety study of an intravenous infusion of a novel therapeutic agent for the treatment of melanoma, osteosarcoma, soft tissue sarcoma or squamous cell carcinoma in dogs: A multi-center study

Eligibility Requirements
To qualify for enrollment in this study, dogs must have:
• Histologic or cytologic diagnosis of cancer (biopsy or needle aspirate)
• There is at least 1 tumor (melanoma, osteosarcoma, soft tissue sarcoma, or squamous cell carcinoma) which can be measured (minimum 1 cm in diameter);
• Generally feeling well (i.e. eating, drinking, ambulating on their own, etc.)
• No evidence of an active bacterial infection requiring antibiotics (other than topical medications) in the past 7 days;
• No anti-cancer therapy within the past 21 days. This includes chemotherapy, radiation therapy, prednisone (or other forms of corticosteroids), and immunotherapy; No tumors where abscess (infection) would result in major symptoms

Study Objective
The primary objective of this multi-institutional exploratory study is to describe the safety and efficacy of three dosages of an intravenous infusion of C. novyi-NT spores, with and without concomitant therapy, in dogs with spontaneous tumors.

Compensation
The study sponsor will pay for therapeutic agent, diagnostic tests, and follow-up evaluations. In the event that side effects are noted and attributed to the therapeutic agent, the study will pay for medical management of the side effects. Please click on the link for more details.

Location of Trial
Columbus, OH

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Study NA Pilot Study to Assess Feasibility of Tissue Collections and Molecular Profiling for future Comparative Oncology Personalized Medicine

Eligibility Requirements
One of the following:
• Scottish terriers with transitional cell carcinoma of the bladder
• Golden retrievers with multi-centric lymphoma
• American cocker spaniels with oral melanoma
• creatinine > 3.0
• bilirubin > 2.0 or elevated bile acids
• HCT < 25%, platelets < 50,000
• any >grade 2 hematologic/biochemical abnormality

Study Objective
A pilot study in pet dogs with cancer is needed to determine the feasibility of tissue collection, clinical utility, and large-scale target interrogation across a multi-institutional setting. Data from this feasibility study will inform the design of a personalized therapeutic intent trial in pet dogs. Future comparative oncology modeling of novel personalized medicine strategies will hopefully progress the field and translate into more efficient targeted therapy prescriptions for human cancer patients.

Compensation
Please contact NCI for further information.

Location of Trial
Colorado State University
Purdue University
Tufts University
University of California at Davis
University of Florida
University of Georgia
University of Guelph
University of Michigan
University of Pennsylvania
University of Tennessee
University of Wisconsin

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Dogs With Malignant Melanoma

Eligibility Requirements
• diagnosis of melanoma
• Owners are responsible for the cost of the initial staging (approximately $400-600), blood and urine tests, and examination fees

Study Objective
Malignant melanoma is a highly aggressive cancer that is resistant to standard chemotherapy. Surgery and/or radiation therapy may control the primary tumor, but most dogs die within one year. Tyrosine kinases are proteins that play a key role in regulation of cell growth. Evidence suggests that in humans and companion animals, tyrosine kinases are often abnormally activated leading to uncontrolled cell growth. Masitinib is a tyrosine kinase inhibitor that has been found to prolong the time to disease progression in dogs with mast cell tumors. The purpose of the proposed study is to evaluate the antitumor activity of masitinib when given alone or in combination with currently available treatments for dogs with melanoma. In the proposed study, dogs with melanoma will be randomized to receive masitinib alone, Oncept (Canine Melanoma Vaccine) alone, or masitinib combined with the chemotherapy drug doxorubicin.

Compensation
It appears the study will pay for costs incurred after the initial staging. Please click on the link for more details.

Location of Trial
Madison, Wisconsin

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Analysis of Palladia Pharmacokinetics and Pharmacodynamics at Non-Label Dosing

Eligibility Requirements
• Have a sarcoma, carcinoma, melanoma or other solid tumor (excluding histiocytic sarcoma and hemangiosarcoma) that has either failed standard therapy or for which the owner declines standard therapy
• Have a life expectancy of approximately 90 days
• Have completed any chemotherapy or radiation therapy at least 2 weeks prior to enrollment

Study Objective
The goal of this study is to determine the pharmacokinetics (blood levels) of Palladia given to dogs with cancer at doses lower than that recommended on the label.

Compensation
Palladia will be provided at no cost during, and 6 months after the completion of the study representing a savings of $1500-3000 to owners. The owner is responsible for all other costs including office visits and bloodwork. Please click on the link for more details.

Location of Trial
Columbus, Ohio

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Evaluation of two immunocytokine fusion proteins in tumor bearing dogs

Eligibility Requirements
• histologically confirmed melanoma
• measurable disease that is accessible to serial peripheral measurements
• tumor size that is greater than 2 cm and less than 8 cm in the longest dimension
• favorable performance status
• both newly diagnosed dogs and those with recurrent disease are eligible
• No significant co-morbid illness, which includes but is not limited to renal or hepatic failure, history of congestive heart failure or clinical coagulopathy
• creatinine > 3.0
• bilirubin > 2.0 or elevated bile acids
• HCT < 25%, platelets < 50,000

Study Objective
A pre-clinical trial of two immunocytokines in tumor bearing dogs is intended to define acute and chronic toxicities and activity of these immunotherapeutic agents in a spontaneous tumor model. The trial is divided into two steps: (1) Dose escalation & tolerability study --- in which we expect to gain insight into the optimal dose, and early indication of any anti-tumor activity and (2) Efficacy study with the best-chosen dose.

Compensation
Please click on the link for more details..

Location of Trial
Colorado State University
University of California at Davis
University of Wisconsin at Madison
University of Missouri
Texas A&M University
Tufts University
University of Tennessee

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P.A.G.

Eligibility Requirements
• Any prospective patient must be examined by the VMTH Oncology or Radiation Oncology service veterinarian, and require the following baseline evaluations at the owners expense before a dog can be considered for enrollment in the trial.
• Confirmed diagnosis of lymphoma or oral malignant melanoma
• Physical examination with weight recorded
• CBC, Chemistry Panel and Urinalysis All within two weeks of enrollment (referring blood work is acceptable as long as it was run at a commercial lab)
• Baseline Evaluation for Eligibility
• Histologically or cytologically confirmed disease
• Measurable and biopsiable tumor
• Ability to stay overnight
• Dog has to be greater than 10k
• Informed owner consent

Study Objective
The goal of this study is to evaluate the efficacy of using the enzyme Pegylated Arginine Deiminase (non-chemotherapy drug) as a subcutaneous injection.

Compensation
This study is fully funded. Please contact the Oncology department for more information. This is a Phase I study. Please click on link for more details.

Location of Trial
Davis, CA

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DTIC for the treatment of canine melanoma

Eligibility Requirements
• Dogs must have a measurable tumor either at the primary site of metastasis, and dogs must be in good clinical condition.
• Dogs whose life expectancy in less than 3 montsh or who have significant liver disease are NOT eligible for participation.

Study Objective
The goal of this study is to determine the efficacy of DTIC in treating dogs with this highly malignant cancer.

Compensation
This study is partially funded. Please click on the link to get more details.

Location of Trial
North Grafton, MA

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IL-12 gene therapy for enhancing therapeutic efficacy of Bleomycin against oral tumors

Eligibility Requirements
• Dogs must have a histopathological diagnosis of oral SCC, oral melanoma or acanthomatous ameloblastona
• Dogs with local or regional but not systemic metastatic disease are eligible for treatment
• Dogs with anticipated survival time without treatment of more than 2 months
• Dogs CANNOT have any history of clinically significant hepatic and/or renal toxicity.

Study Objective
The objective of this study is to evaluate the clinical response of canine oral SCC, oral melanoma or acanthomatous ameloblastoma treated with combination IL-12 and Bleomycin electrochemotherapy vs. Bleomycin electrochemotherapy or IL-12 electrochemotherapy alone.

Compensation
This study is fully funded if you go to LSU. This study is partially funded if you pursue treatment at VOHC. Please click on LSU link for more details.

Location of Trial
Baton Rouge, LA: More information
Norwalk, CT: More information

 
Melanoma vaccine study in dogs with malignant melanoma

Eligibility Requirements
• Dogs must have a diagnosis of malignant melanoma confirmed by histopathology/cytology
• Must have resectable desiease or minimal disease
• Must not have any other life threatening diseases

Study Objective
No objective was listed on the website. The study is using a vaccine containing a melanoma antigen that could induce an antibody response in dogs. They have also shown that the vaccine could stimulate peripheral blood natural killer cells to kill melanoma target cells in a laboratory test.

Compensation
This study is partially funded. Please click on link for more details.

Location of Trial
Gainesville, FL

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Liposomal clodronate in canine cancer (excluding mast cell tumor, hemangiosarcoma and malignant histiocytosis)

Eligibility Requirements
• Dogs with biopsy-confirmed cancers (excluding mast cell tumor, hemangiosarcom and malignant histiocytosis) are potentially eligible
• The tumor must be less than 8cm (approximately 3.5 inches) in diameter and located in an easily accessible area for biopsy.
• Dogs must have good function of liver and kidneys and acceptable blood cell counts.
• Dogs must be free of underlying disease.
• OWNERS MUST CONSENT TO A POSTMORTEM EXAM (AUTOPSY) AT THE TIME THEIR PET DIES OR IS EUTHANIZED.

Study Objective
The goals of this study are to demonstrate liposomal clodronate as a safe and effective cancer therapy and to determine the anti-tumor activity of liposomal clodronate against a variety of canine tumors.

Compensation
This study is partially funded. Please click on link for more details.

Location of Trial
Fort Collins, CO

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Canine patients with osteosarcoma, lymphoma, or oral malignant melanoma, mast cell tumors, soft tissue sarcomas/histiocytic sarcoma/malignant histiocytosis, primary pulmonary cancer, hemangiosarcomas

Eligibility Requirements
• Requirements vary for each type of cancer listed above. Please click on link for more details.

Study Objective
The goal of the CCOGC and UC Davis will be to populate the Pfizer-CCOGC Biospecimen Repository with diseased tissues and specific normal tissues from dogs with cancer over the next three years.

Compensation
This study is partially funded. Please click on link for more details.

Location of Trial
Davis, CA: More Information
North Grafton, MA: More Information
Madison, WI: More Information

 
Satraplatin for any tumor, including lymphoma

Eligibility Requirements
• Any tumor, including lymphoma confirmed by histopathology or cytology

Study Objective
To determine efficacy of using Satraplatin for various types of cancer using 5mg/m2 daily (orally).

Compensation
This study is partially funded. Please click on link for more details.

Location of Trial
Columbia, MO

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Alteration of the intestinal microflora after chemotherapy in dogs

Eligibility Requirements
• Your 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 of a certain size (2-8 cm in the longest diameter) and your dog must have no other significant health problems. This study also includes dogs with only a single site as well as dogs with metastatic (spread of the tumor to other locations) disease.

Study Objective
The objective of this study is to test s new probiotic enzyme to reduce chemotherapy induced diarrhea.

Compensation
All costs associated with this study will be provided as part of your participation. In the event any complications arise during the twenty-eight (28) day study period (time period between drug administration and assessment), their management will be covered by study funds up to $2000/dog/event. This would include any unanticipated hospitalizations. However, all costs exceeding $2000/dog/event are your responsibility. Please click on link for more details.

Location of Trial
College Station, TX

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“Smokey taught me the value of leaving no stone unturned in the search for better therapies and
the importance of hope.”
               - Dr Gerald Post