Hypofractionated radiation therapy combined with the ONCEPT canine melanoma vaccine for canine oral melanoma

The Veterinary Radiation Therapy Oncology Group consists of a group of board-certified radiation oncologists across the nation dedicated to cooperative clinical trials to improve the survival of animals with cancer. The team at Tufts’ Foster Hospital for Small Animals is part of this consortium and is currently enrolling patients.  This organization is currently conducting an independent study to evaluate the treatment of canine oral malignant melanoma with coarse-fraction radiotherapy (8 Gy for 4 weekly fractions) in combination with the ONCEPT™ melanoma vaccine. Data for three treatment groups (concurrent radiation therapy and vaccine; radiation therapy alone; vaccine alone) will be collected.  Given that the study is not funded, treatment selection will be based on owners preference.  The primary objective of this study is to compare tumor progression between the treatment groups with a secondary objective of evaluating overall survival time.

Inclusion criteria for the study are as follows: (1) dogs must have a histologically or cytologically confirmed oral melanoma (including lip and lingual tumors); (2) treatment must follow the protocol outlined by the study; and (3) tumor staging and follow-up must be adequate (tumor measurements, mandibular lymph node evaluation, and thoracic radiographs).  Dogs with distant metastasis (beyond the mandibular lymph node) and dogs receiving concurrent chemotherapy are excluded. Dogs not receiving NSAID therapy are preferred because of the possible confounding anti-tumor effects of these drugs. However, there are no restrictions to therapy at the time of progressive disease.

The radiation therapy protocol involves four weekly fractions of 8 Gy for a total dose of 32 Gy. The ONCEPT™ melanoma vaccine will be administered every 2 weeks for four immunizations and a booster will follow every 6 months. It is preferred that the first vaccination be delivered at the time of the first radiation treatment. Follow-up examinations and thoracic radiographs are required at a minimum of every 6 months following completion of therapy.