Vaccine Therapy With or Without Imiquimod 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 Stage II-IV disease Has undergone surgical resection within the past 12 months No clinical or radiological evidence of disease after surgical resection Must have ≥ 1 undissected axillary and/or inguinal lymph node basin HLA-A1, -A2, or -A3 positive Ineligible for OR refused interferon PATIENT CHARACTERISTICS: Age 12 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 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% (for patients with diabetes) No medical contraindication or potential problem that would preclude study compliance 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 Prior vaccinations that resulted in recurrent disease during or after vaccine administration allowed provided the last vaccination was administered more than 12 weeks ago Prior multi-epitope melanoma peptide vaccine that resulted in a negative immune response allowed 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 vaccine for at least 2 weeks before or after study vaccine administration Chemotherapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas [e.g., carmustine or lomustine]) No concurrent chemotherapy, including nitrosoureas Endocrine therapy More than 4 weeks since prior and no concurrent oral or parenteral corticosteroids (e.g., prednisone) No prior or concurrent inhaled steroids (e.g., Advair®, Flovent®, Azmacort®) Concurrent topical corticosteroids allowed Radiotherapy More than 4 weeks since prior and no concurrent radiotherapy Prior stereotactic radiosurgery allowed provided it was completed within the past 12 months Surgery See Disease Characteristics More than 4 weeks since prior surgical resection of metastatic lesion(s) No concurrent surgery requiring general anesthesia 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 No other concurrent immunosuppressive therapy
Sites / Locations
- University of Virginia Cancer Center