Vaccine Therapy and Sargramostim in Treating Patients With Stage IV Malignant Melanoma
Recurrent Melanoma, Stage IV Melanoma

About this trial
This is an interventional treatment trial for Recurrent Melanoma
Eligibility Criteria
Inclusion Criteria: Human leukocyte antigen (HLA)-A2 positive Histologic proof of stage IV malignant melanoma with measurable disease Absolute neutrophil count (ANC) >= 1500 Platelets (PLT) >= 100,000 Alkaline phosphatase (Alk phos) =< 3 x upper limit of normal (ULN) Aspartate aminotransferase (AST) =< 3 x ULN Creatinine (Creat) =< 1.5 x ULN Hemoglobin (Hgb) > 9.0 Ability to provide informed consent Willingness to return to a Mayo Clinic institution for follow-up Life expectancy >= 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 Exclusion Criteria: Uncontrolled or current infection Prior immunization with differentiation antigen peptides Known standard therapy for the patient's disease that is potentially curative or proven capable of extending life expectancy Any of the following prior therapies: Chemotherapy =< 4 weeks Mitomycin C/nitrosoureas =< 6 weeks Immunotherapy =<4 weeks Biologic therapy =< 4 weeks Radiation therapy =< 4 weeks Radiation to > 25% of bone marrow Failure to fully recover from effects of prior chemotherapy regardless of interval since last treatment New York Heart Association classification III or IV Seizure disorder Any of the following: Pregnant women Nursing women Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) Other concurrent chemotherapy, immunotherapy, or radiotherapy Active psychiatric disorder requiring medications (anti-psychotics) Known central nervous system metastases or carcinomatous meningitis History of other malignancy in last 5 years with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only (it is impossible to predict the effect of study treatment on other, potentially dormant malignant diseases) Known immune deficiency (patients with known immune deficiencies will likely not be able to mount an immune response to the study vaccine)
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Arm I (vaccine therapy)
Arm II (vaccine therapy and lower-dose sargramostim)
Arm III (vaccine therapy and higher-dose sargramostim)
Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant SC on day 1 of weeks 0, 3, 6, 9, 12, and 24.
Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant SC and lower-dose sargramostim SC on day 1 of weeks 0, 3, 6, 9, 12, and 24.
Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant SC and higher-dose sargramostim SC on day 1 of weeks 0, 3, 6, 9, 12, and 24.