Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma
Melanoma (Skin)
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage IV or recurrent melanoma Metastatic disease confirmed by MRI or CT scan Planned resection of tumor No active CNS metastases Radiographically confirmed lack of CNS disease progression No requirement for pharmacologic doses of corticosteroids PATIENT CHARACTERISTICS: Age: Over 16 Performance status: ECOG 0-2 Life expectancy: At least 4 months Hematopoietic: Hematocrit greater than 25% Platelet count greater than 100,000/mm^3 No ongoing transfusion requirements No active blood clotting or bleeding diathesis Hepatic: Bilirubin no greater than 2.0 mg/dL Albumin at least 3.0 g/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No underlying cardiac disease associated with known myocardial dysfunction No unstable angina related to atherosclerotic cardiovascular disease Other: No other malignancy within the past 5 years except for carcinoma in situ, basal cell carcinoma, or localized squamous cell skin cancer No active, eminently life-threatening infection or medical condition Adequate venous access Not pregnant Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Other prior putative vaccines allowed Recovered from prior biologic therapy No other concurrent biologic therapy except epoetin alfa for patients with hematocrit less than 36% Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent endocrine therapy Radiotherapy: At least 3 weeks since prior radiotherapy (including whole brain radiotherapy) and recovered No concurrent radiotherapy Surgery: See Disease Characteristics Recovered from prior surgery Other: Concurrent bisphosphonates allowed for patients with lytic bone metastases No concurrent digoxin or other medications designed to improve cardiac output No other concurrent investigational therapy
Sites / Locations
- Hoag Cancer Center at Hoag Memorial Hospital Presbyterian
Arms of the Study
Arm 1
Experimental
Biological/Vaccine
Biological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.