Vaccine Therapy in Treating Patients With High-Risk Stage III or Completely Resected Metastatic M… (NCT00019890) | Clinical Trial Compass
CompletedPhase 2
Vaccine Therapy in Treating Patients With High-Risk Stage III or Completely Resected Metastatic Melanoma
Plain-language summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have high-risk stage III or completely resected metastatic melanoma.
Who can participate
Age range16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- High risk stage III melanoma (greater than 3 lymph nodes positive) OR completely resected metastatic melanoma within 6 months of surgery Disease free by CT scan HLA-A201 positive --Prior/Concurrent Therapy-- Biologic therapy: At least 4 weeks since prior biologic therapy No prior MART-1 or gp100 peptide immunization No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior endocrine therapy No concurrent systemic steroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics No concurrent surgery --Patient Characteristics-- Age: 16 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorder Hepatic: Bilirubin no greater than 1.6 mg/dL AST or ALT less than 3 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major cardiac disease Pulmonary: No major pulmonary disease Other: Not pregnant or nursing Fertile patients must use effective contraception No active systemic infection No autoimmune disorders HIV negative Hepatitis B surface antigen negative