Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent, Canvaxin™
Response of In-Transit Melanoma to Systemic Treatment With the Specific Active Immunotherapeutic Agent, Canvaxin™
RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase II trial is studying vaccine therapy to see how well it works in treating patients with malignant melanoma.
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study.
Patients receive polyvalent melanoma vaccine (Canvaxin™) subcutaneously to the armpit and groin areas every 2 weeks for approximately 10 weeks (5 doses) and then every 4 weeks for up to approximately 1 year of total treatment (total of 15 doses). Patients with no evidence of response at week 24 receive no further treatment. Patients whose disease continues to respond after completion of study treatment are eligible for a new study in which they will continue treatment with polyvalent melanoma vaccine (Canvaxin™).
After completion of study treatment, patients are followed at 30 days.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Palm Springs, California 92262, United States
Santa Monica, California 90404, United States
Lakeland, Florida 33804-1057, United States
Tampa, Florida 33612-9497, United States
Philadelphia, Pennsylvania 19104-4283, United States
Dallas, Texas 75390, United States