Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Who Have Undergone Surgery for Stage II, Stage III, or Stage IV Melanoma
Melanoma (Skin)
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage II melanoma, stage III melanoma, stage IV melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed melanoma Cutaneous, mucosal, or primary melanoma Stage IIB-IV disease Has undergone surgical resection or stereotactic radiosurgery for malignant melanoma ≥ 1 week but ≤ 6 months ago No clinical or radiological evidence of disease after surgical resection or stereotactic radiosurgery by chest x-ray or CT scan*, abdominal and pelvic CT scan*, and head CT scan or MRI NOTE: *Positron emission tomography scan/CT fusion scan may replace scans of the chest, abdomen, and pelvis Must have ≥ 2 intact (undissected) axillary and/or inguinal lymph node basins HLA-A1, -A2, or -A3 positive AND HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive Ineligible for OR refused interferon No ocular melanoma Brain metastases allowed provided all of the following criteria are met: No more than 3 total brain metastases Each metastasis ≤ 2 cm in diameter at the time of study entry Each metastasis was completely removed by surgery or treated with stereotactic radiosurgery No evidence of brain metastasis progression since the most recent treatment PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count > 1,000/mm^3 Platelet count > 100,000/mm^3 Hemoglobin > 9 g/dL Hepatic AST and ALT ≤ 2.5 times upper limit of normal (ULN) Bilirubin ≤ 2.5 times ULN Lactic dehydrogenase ≤ 1.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Hepatitis C negative Renal Creatinine ≤ 1.5 times ULN Cardiovascular No New York Heart Association class III or IV heart disease Immunologic HIV negative No known or suspected allergy to any component of the study vaccines No autoimmune disorder with visceral involvement No prior or active autoimmune disorder requiring cytotoxic or immunosuppressive therapy The following immunologic conditions are allowed: Laboratory evidence of autoimmune disease (e.g., positive anti-nuclear antibody titer) without symptoms Clinical evidence of vitiligo Other forms of depigmenting illness Mild arthritis requiring non-steroidal anti-inflammatory drugs Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Weight ≥ 110 lbs No uncontrolled diabetes Hemoglobin A1C < 7% No medical contraindication or potential problem that would preclude study compliance No other malignancy except squamous cell or basal cell skin cancer without known metastasis, carcinoma in situ of the breast (ductal or lobular) or cervix, or other successfully treated cancer without distant metastasis with no evidence of recurrence or metastasis for > 5 years No known active addiction to alcohol or drugs No recent (within the past year) or ongoing illicit IV drug use PRIOR CONCURRENT THERAPY: Biologic therapy No prior vaccination with any of the synthetic peptides used in this study Prior vaccinations (containing agents other than the synthetic peptides used in this study) that resulted in recurrent disease during or after vaccine administration allowed provided the last vaccination was administered more than 12 weeks ago More than 4 weeks since prior and no concurrent interferon (e.g., Intron-A®), interleukins (e.g., Proleukin®), or growth factors (e.g., Procrit®, Aranesp®, or Neulasta®) More than 4 weeks since prior and no concurrent allergy desensitization injections No influenza vaccines for at least 2 weeks before or after study vaccine administration Chemotherapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) No concurrent chemotherapy, including nitrosoureas Endocrine therapy More than 4 weeks since prior and no concurrent oral or parenteral corticosteroids No prior or concurrent inhaled steroids (e.g., Advair®, Flovent®, or Azmacort®) Prior or concurrent topical corticosteroids allowed Radiotherapy See Disease Characteristics More than 4 weeks since other prior and no concurrent radiotherapy Surgery See Disease Characteristics Other More than 4 weeks since prior and no other concurrent investigational agents More than 30 days since prior and no concurrent participation in another clinical study
Sites / Locations
- Fox Chase Cancer Center - Philadelphia
- M. D. Anderson Cancer Center at University of Texas
- University of Virginia Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Arm I
Arm II
Arm III
Arm IV
Patients receive vaccine comprising multi-epitope melanoma peptides, tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.
Patients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine comprising multi-epitope melanoma peptides, tetanus toxoid helper peptide emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.
Patients receive vaccine comprising melanoma peptides and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.
Patients receive cyclophosphamide IV over 30-60 minutes on day -4. Patients then receive vaccine comprising melanoma peptides and multi-epitope melanoma helper peptides emulsified in Montanide ISA-51 intradermally and subcutaneously on days 1, 8, 15, 29, 36, 43, 85, 183, 274, and 365.