A Phase I Trial of Intra Lesional RV-B7.1 Vaccine in the Treatment of Malignant Melanoma

Date de début de l'étude : 1 octobre 1999

DISEASE CHARACTERISTICS: Histologically proven metastatic, unresectable melanoma Dermal, subcutaneous, or lymph node metastases Accessible for injection Lesions must measure at least 1 cm Patients with no prior treatment allowed Patients must have one of the following as proof of prior vaccinia immunization: Physician certification Recollection and appropriate vaccination scar site No encephalitis, untreated cerebral metastases, other structural brain lesions, or leptomeningeal disease No ascites or pleural effusions No leukemia or lymphoma PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 Karnofsky 80-100% Life expectancy: Greater than 3 months WBC greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 10g/dL Bilirubin less than 1.5 mg/dL Transaminases no greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2 times ULN PT/PTT no greater than 2 fold elevation in patients not receiving anticoagulation medications No alcoholic cirrhosis Creatinine less than 2.0 mg/dL OR creatine clearance greater than 60 mL/min No congestive heart failure No serious cardiac arrhythmias No recent prior myocardial infarction No clinical coronary artery disease No chronic obstructive pulmonary disease Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No seizure disorders No underlying immunosuppressive disorder No autoimmune disease HIV negative No skin diseases No open wounds No eczema or other contraindications to vaccinia virus administration Patients must be able to avoid high risk individuals (e.g., immunosuppressed patients, children under 3 years, pregnant women, patients with active or a history of eczema, or patients with other skin conditions) for 7-10 days following treatment No significant allergy or hypersensitivity to eggs No active or chronic infections No concurrent medical illness No other significant medical disease which would increase risk to patient No other prior malignancy within the past 5 years except stage I carcinoma of the cervix or basal cell carcinoma PRIOR CONCURRENT THERAPY: At least 8 weeks since prior immunotherapy and recovered No prior live pox virus vector No more than 2 prior chemotherapy regimens At least 4 weeks since prior chemotherapy and recovered At least 4 weeks since prior systemic corticosteroids No systemic corticosteroids for concurrent illness No concurrent immunosuppressive steroids At least 2 weeks since prior radiotherapy and recovered (no bone marrow toxicity) At least 6 months since prior radiotherapy for brain metastases and recovered At least 4 weeks since prior surgery for management of the primary or metastatic lesions and recovered with remaining measurable disease At least 6 months since prior surgery for brain metastases and recovered No concurrent immunosuppressive drugs