Clinical Trials
Cell Therapy for Metastatic Osteosarcoma
CAR iNKT cell therapy for metastatic osteosarcoma
In this study we will investigate the therapeutic potential of a type of white blood cell known as invariant natural killer T (iNKT) cells that are made from the blood of a healthy donor dog. iNKT cells are potent immune cells that kill cancer cells in mouse models and in some human cancer patients. In this study, we will use iNKT cells that express a cancer targeting receptor known as a chimeric antigen receptor (CAR). The CAR directs the modified iNKT cells to the cancer cells which are then killed. The CAR-iNKT cells also will further activate the patient's own immune system to help kill the cancer cells. The purpose of this study is to determine the safety of CAR-iNKT cells, their maximum tolerated dose, how long they will remain in the patient and their effectiveness against bone cancer that has spread to the lungs.
Contact
Mary Beth Boland
mboland@vet.upenn.edu
Clinical Trials
Oral Melanoma Study
Pilot study to evaluate a fully canine anti-CTLA4 mAb (VGS-001) in combination with radiation therapy in dogs with stage III and IV oral malignant melanoma
Summary: Dogs with oral malignant melanoma may be eligible to participate in a pilot study using a novel anti-cancer immunotherapy. The goal of this study is to evaluate the safety, tolerability, and efficacy of an anti-CTLA4 antibody when combined with radiation therapy in dogs with oral malignant melanoma.
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Details of Study
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Project Description
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An open-label, prospective, multi-institutional, fixed-schedule, prospective pre-clinical trial will be performed to evaluate 4VGS-001 (Anti-CTLA) in combination with radiation therapy in dogs with stage III or IV oral malignant melanoma.
The treatment period is 10 weeks during which 3 doses of radiation therapy will be administered over a one-week period followed by 4 doses of VGS-001 given at 3-week intervals. The total observation period will be 29 weeks. During this time, dogs will be evaluated for objective response (CR, PR, or SD). Dogs will be evaluated on an intent-to-treat basis. Dogs with documented progressive disease (increase in size of either the primary tumor or metastatic lesions) will undergo re-evaluation 2 weeks later to confirm disease progression and not pseudoprogression. Overall tolerability and biological activity will be based on clinical and pharmacodynamic endpoints.
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Locations
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University of Missouri, Colombia, Missouri
North Carolina State University,Raleigh, North Carolina
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Study Type
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Interventional
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Intervention
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Biologic/vaccine
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Inclusion Criteria
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Dogs with a histopathological diagnosis of oral malignant melanoma (+/- documented LN involvement)
Inoperable or incompletely excised tumor
Stage III (primary tumor ≥4cm in diameter, or presence of lymph node metastases) or IV (distant metastasis) (historical MST with RT alone of 159 days and 90 daysrespectively)
Body weight >5kg
Modified ECOG score: Grade 0 or grade I
Newly diagnosed or relapsed
No significant co-morbidities
Expected survival time of at least 2 months at the time of enrollment (assumingreceipt of standard radiotherapy)
Informed owner consent
Owner
At least 18 years of age.
Ability to give informed consent and ability to read, understand and fill out questionnaires.
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Exclusion Criteria
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History of autoimmunity, immune-mediated disease (e.g., IMHA, ITP, IMPA etc.), colitis, IBD, endocrine disorders (e.g., hypothyroidism, hypoadrenocorticism, etc.) or hepatopathies (AST or ALT >1.5x ULN; bilirubin >2.0mg/dL)
Received chemotherapy, radiation therapy or immunotherapy within the last 4 weeks.
Significant co-morbidities: Creatinine > 3.0 mg/dL; Bilirubin > 2.0 mg/dL, or elevated bile acids; HCT < 25%, or platelets <50,000/μL; Any >grade 2 hematologic or biochemical abnormality
Glucocorticoid therapy within the last 7 days
Daily drug administration (insulin, fludrocortisone, etc.) for the control of unregulated chronic disease
Concurrent use of either CYTOPOINT or APOQUEL
Body weight >60kg
Clinically significant metastatic disease
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Potential Medical Benefits to Enrolled Animals
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Anti-tumor effect & potential extension of life
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Potential Medical Risks to Enrolled Animals
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Common infusion-related adverse events in humans include:
Fatigue
Nausea and vomiting
Diarrhea
Fever
Headache
Dizziness
Rash
Pruritus
Hypotension
Tachycardia
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Financial Incentives for Study Participants
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Costs associated with novel immunotherapy, radiation therapy, blood and tissue collections, and monitoring visits are covered.
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Bladder Cancer Study
Pilot study to evaluate the safety and pharmacodynamic effects of a fully canine anti-PD1 antibody in pet dogs with urothelial carcinoma
Summary: Dogs with urothelial carcinoma may be eligible to participate in a clinical trial. This study seeks to evaluate a novel immunotherapy that specifically targets an important molecule primarily expressed on immune cells. This molecule usually turns off the immune cells and prevents overactive immune responses. However, it also turns off anti-cancer immune responses and prevents the immune system controlling and killing cancer cells. Immunotherapies that can inhibit this molecule on immune cells that recognize cancer cells could make it possible for the immune system to recognize and attack the underlying cancer more effectively. This study seeks to evaluate the tolerability and efficacy of this novel immunotherapy in dogs with urothelial carcinoma.
Contact
Samuel Stewart
sstewart@ethosvet.com
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Details of Study
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Project Description
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Urothelial carcinoma (also known as transitional cell carcinoma) is the most common type of bladder cancer to affect dogs. Treatment often involves a combination of surgery, chemotherapy, and radiation therapy, with the aim being to reduce the size of the tumor, alleviate symptoms, and improve the dog's quality of life. In recent years, immunotherapy has emerged as a promising treatment approach for many types of cancer, including canine urothelial carcinoma. Immunotherapies aim to harness the body's immune system to recognize and attack cancer cells. They can be particularly attractive for treating cancers that are difficult to access surgically or that have metastasized (spread to other parts of the body).
This study seeks to evaluate a novel immunotherapy when used in dogs with urothelial carcinoma. The therapy specifically targets an important molecule primarily expressed on immune cells, which usually turns off the immune cells and prevents overactive immune responses. However, it also turns off anti-cancer immune responses and prevents the immune system controlling and killing cancer cells. Immunotherapies that can inhibit this molecule on immune cells that recognize cancer cells could make it possible for the immune system to recognize and attack the underlying cancer more effectively. Urothelial carcinoma in dogs shares many biological and molecular features with human urothelial carcinoma, including their ability to be shielded from the immune system. Human clinical trials in urothelial carcinoma investigating similar immunotherapies have shown these therapies to be more effective than traditional chemotherapies in some cases. Development of an immunotherapy that is safe and beneficial in canine urothelial carcinoma patients will advance veterinarians ability to treat this disease and will provide an important model to inform future canine and human clinical trials in this area. This study seeks to evaluate the tolerability and efficacy of this novel immunotherapy in dogs with urothelial carcinoma.
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Locations
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Veterinary Specialty Hospital – North County San Marcos, California
Colorado Animal Specialty & Emergency
Boulder, Colorado
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Study Type
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Interventional
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Intervention
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Drug
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Inclusion Criteria
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Weigh ≥5kg and ≤35kg
Histologically confirmed urothelial carcinoma, with or without documented lymph node involvement (both newly diagnosed dogs and those with recurrent/relapsed disease are eligible)
Measurable tumor burden with primary intravesicular tumor amenable for cystoscopic biopsy
ECOG performance status of grade 0 or 1
Adequate hematologic, hepatic, and renal function
Creatinine ≤2.0 mg/dL
No significant comorbidities
Expected survival time of at least 8 weeks
Signed informed owner consent
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Exclusion Criteria
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Body weight of <5kg or >35kg
Pulmonary metastatic disease
History of any diagnosed or suspected autoimmune or immune-mediated disease, colitis, IBD, endocrine disorders
Significant comorbidities
Symptomatic urinary tract infection confirmed on urine culture
Any >grade 2 hematologic or biochemical abnormality
History of daily drug administration for unregulated chronic disease
Prior experimental therapy
Prior antibody therapies
Prior immunomodulatory therapies within six weeks of study enrollment.
Dogs receiving standard of care NSAID for UC for at least 2 weeks prior to study enrollment will be allowed to continue while on study
Concurrent chemotherapy or radiation therapy within 2 weeks of study enrollment
Treatment with corticosteroids within 7 days of study enrollment
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Potential Medical Benefits to Enrolled Animals
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Possible improvement in the status of your dog's urothelial carcinoma.
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Potential Medical Risks to Enrolled Animals
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The risk for complications from the routine diagnostics and imaging performed for the study are considered to be very low. Several study visits will require sedation or general anesthesia, which can be associated with complications. The veterinarian overseeing your dog’s care will discuss the potential complications associated with the sedation/anesthesia plan they intend to use in your dog.
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Financial Incentives for Study Participants
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Fully funded including initial screening
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Explore more of Penn Vet's clinical trials to get involved and learn more about our cutting-edge Cancer Research at the school.
The AVMA Veterinary Clinical Trials Registry can also be a resource to help you find a trial for your pet.
