Rhode Island Hospital recruiting patients for study of new drug to treat malignant metastatic melanoma
(posted July 15, 2009)
Rhode Island Hospital is participating in a clinical trial to evaluate a new drug for malignant metastatic melanoma.
The trial will study a new drug, Allovectin-7, and its safety and effectiveness compared to other drugs. Approximately 375 patients will be enrolled in the study so researchers can evaluate patients’ response rate and survival. The 2-year study will include regular assessments, which will be performed at pre-trial, at week 16 and at the end of every 8 weeks for up to 12 months, then every 12 weeks for the second year.Patients enrolled in the trial will be part of a randomized trial, and will be randomly assigned to either the group receiving Allovectin-7 or to a group who receives standard chemotherapy that serves as a control.
To be eligible, patients must be 18 years of age or older, have confirmed recurrent malignant metastatic melanoma, which may have been treated through primary surgical resection, adjuvant therapy and/or biotherapy. Patients must have an injectable lesion greater than one centimeter but less than 25 centimeters. Patients with surgery as a curative option cannot participate in the trial. Other exclusionary criteria apply, including patients with malignant metastatic melanoma in organs other than the lung or patients who have had prior chemotherapy. Patients who are currently undergoing radiation therapy, immunosuppressive therapy or biologic therapy must discontinue treatment four weeks prior to trial entry.
Recruitment for the study is ongoing. For more information, contact study coordinator Denise Henderson in the Rhode Island Hospital cancer research center at 401-444-5014.