Ongoing Trials

COTC005: Evaluation of immunocytokine fusion protein in tumor bearing dogs.

Sponsor: Pharmaceutical Company

Purpose: A pre-clinical trial of immunocytokine in tumor bearing dogs is intended to define acute and chronic toxicities and activity of this immunotherapeutic agent 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.

Participating Sites:
The Ohio State University
Cornell University
University of California at Davis
Tufts University
University of Tennessee

Study Numbers: 10-15 dogs will be enrolled to the first phase of this study.

Eligibility Requirements:

• histologically confirmed lymphoma melanoma or soft tissue sarcoma Favorable performance status
• both newly diagnosed dogs and those with recurrent disease are eligible
• Dogs cannot receive concurrent chemotherapy, radiation or angiogenesis for 3 weeks prior to study enrollment
• no current or of history of immune mediated disease (IMHA, ITP, SLE, etc)

Closed Trials

COTC001: Evaluation of RGD Targeted Delivery of Phage Expressing TNF-alpha to Tumor Bearing Dogs.

Sponsor: The National Cancer Institute

Purpose: This clinical trial sponsored by the National Cancer Institute (NCI) evaluates the safety and effectiveness of the phage-based delivery of an agent known as Tumor Necrosis Factor (TNF alpha). TNF alpha is known to kill cancer cells and the blood vessels that feed them. It is currently used in human cancer patients as an isolated infusion and efforts to find new ways to deliver it safely have been underway for some time. The NCI has developed a special way to deliver TNF-alpha specifically to blood vessels around tumors using a molecular approach based on a viral-like carrier (phage). Results of this trial in dogs will be used to inform the design and implentation of planned clinical trails in human cancer patients.

Participating Sites:
Colorado State University
University of Missouri
University of Pennsylvania
University of Tennessee
University of Wisconsin

Study Numbers: 15-20 dogs will be enrolled in each study

Eligibility Requirements:

• Hisotogically confirmed, Measurable disease (<2cm), can be primary and/or metastatic
• Favorable performance status
• Naïve or recurrent disease
• Dogs must be more than 15kg
• Dogs cannot receive concurrent chemotherapy, radiation or angiogenesis for 4 weeks prior to study enrollment

COTC003 Study 1: Evaluation of the MTOR inhibitor Rapamycin in dogs with osteosarcoma

Sponsor: Morris Animal Foundation and The Center for Cancer Research, NCI. Scientific endorsement from the Children’s Oncology Group and the Sarcoma Alliance for Research through Cooperation (SARC).

Purpose: This clinical trial seeks to identify a safe, pharmacokinetically/ pharmacodynamically relevant dose of Rapamycin in tumor bearings dogs. Currently, Rapamycin is approved as an immunosuppressive agent used in the setting of organ and bone marrow transplant. Results of this trial will directly inform the development efforts of Rapamycin analogues currently underway by providing the groundwork for follow-up studies that will assess optimal Rapamycin dose and schedule.

Participating Sites:
Colorado State University
The Ohio State University
University of Illinois
University of Wisconsin

Study Numbers: 20-25 dogs will be enrolled

Eligibility Requirements:

• Hitologically confirmed, osteosarcoma
• Favorable performance status
• Measurable disease that is amenable to serial biopsy
• No concurrent chemotherapy or radiation therapy for 2 weeks prior to study enrollment

Upcoming Trials

COTC003 Study 2: Evaluation of the MTOR inhibitor Rapamycin in dogs with osteosarcoma.

Sponsor: Morris Animal Foundation and The Center for Cancer Research, NCI. Scientific endorsement from the Children’s Oncology Group and the Sarcoma Alliance for Research through Cooperation (SARC).

Purpose: The second study of this clinical trial seeks to confirm the safety of chronic rapamycin administration, at the dose defined in study 1, in dogs with radiographically measurable osteosarcoma pulmonary metastases. Currently, Rapamycin is approved as an immunosuppressive agent used in the setting of organ and bone marrow transplant. Results of this trial will directly inform the development efforts of Rapamycin analogues currently underway by providing the groundwork for follow-up studies that will assess optimal Rapamycin dose and schedule.

Participating Sites:
Colorado State University
The Ohio State University
University of Illinois
University of Wisconsin

Study Numbers: 20-25 dogs will be enrolled

Eligibility Requirements:

• Radiographically measurable osteosarcoma pulmonary metastases
• Pulmonary metastatic burden
• Favorable performance status
• No concurrent chemotherapy or radiation therapy for 2 weeks prior to study enrollment

If you are interested in learning more about the eligibility requirements for any of the above studies, please contact the nearest participating University or Christina Mazcko at mazckoc@mail.nih.gov