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Funded Clinical Trial for Newly Diagnosed Canine Lymphoma
Novel Targeted Treatment Approaches
Status: Open
Eligibility:
- Histological diagnosis of lymphoma
- Measurable lymph node enlargement (all stages accepted)
- Newly diagnosed cases
- ICC for CD3 and MDR collected from all cases
- No previous treatment with chemotherapy, antiangiogenic agents or prednisone therapy targeted at lymphoma
Trial Design:
The objective of this study is to determine the safety and efficacy of two investigation medications (an antiangiogenic agent administered subcutaneously and an oral PARP inhibitor). These agents will be given to dogs with lymphoma concurrently receiving a multi-agent chemotherapy protocol including Vincristine, Cytoxan and Prednisone (COP). A placebo will be involved in the study, but all dogs will receive COP chemotherapy. Data will be used in follow-up studies to further define the efficacy of these agents in the treatment of canine lymphoma.
The two investigation medications act by different mechanisms to help treat lymphoma. The injectable antiangiogenic drug, a modified peptide of the naturally occurring thrombospondin-1 protein, prevents new blood vessel formation and targets existing tumor-associated blood vessels, inhibiting tumor growth and progression. The oral PARP inhibitor enhances the efficacy of conventional chemotherapy by preventing tumor cell DNA from repairing itself. Previous studies with both of these investigational medications have resulted in significant objective responses with no identifiable toxicities seen.
Prior to the entering the study, a CBC, chemistry panel, urinalysis, immunophenotyping, and thoracic and abdominal radiographs are required. These diagnostics can be performed at any veterinary hospital within 10 days of patient enrollment. Additional diagnostics may be required to assess the patient’s status while enrolled in this study. Eligible patients will have the opportunity to be treated with one of the investigational compound or placebo while under closely monitored conditions. Dogs will receive their assigned medication over a 42-day initial phase. Patient visits are once weekly for the first 42 days then every 28 days until lymphoma progression or investigator/owner discretion.
Trial Support/Funding:
- Study Agent or Placebo
- All study-required diagnostics after initial consultation to determine eligibility
- 6-week COP chemotherapy protocol
- Maintenance COP chemotherapy
Patients must be treated at a participating Animal Clinical Investigation Network Hospital!
PO Box 42535
Washington, D.C. 20015
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