Fludarabine Followed by Vaccine Therapy and White Blood Cell Infusions in Treating Patients With Unresectable or Metastatic Melanoma
Melanoma (Skin)
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage III melanoma, stage IV melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed malignant melanoma Metastatic or unresectable disease Measurable disease HLA-A2 positive Received at least 1 prior immunotherapy and/or chemotherapy regimen for metastatic disease (first 6 patients only) No known brain metastases unless previously treated with radiotherapy and/or surgery AND is stable for at least 1 month after treatment PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy More than 3 months Hematopoietic WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Absolute lymphocyte count ≥ 500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL (transfusions allowed) Hematocrit ≥ 24% No other active bleeding Hepatic Bilirubin < 2 times upper limit of normal (ULN) (unless due to Gilbert's disease) AST and ALT < 3 times ULN Hepatitis B surface antigen negative Hepatitis C antibody negative Renal Creatinine < 2 mg/dL No uncontrolled hypercalcemia Cardiovascular No uncontrolled symptomatic congestive heart failure No unstable angina pectoris No uncontrolled cardiac arrhythmia No uncontrolled hypertension Pulmonary No uncontrolled bronchospasm No hemoptysis Immunologic Negative serology for all of the following: HIV-1 and HIV-2 HTLV-1 and -2 Syphilis Rheumatoid factor < 43 units/μL Anti-nuclear antibody < 11 units/μL No history of multiple sclerosis, systemic lupus erythematosus, or myasthenia gravis No primary or secondary immunodeficiency No active infection No allergy to seafood or shellfish that would preclude study participation Other No active gastrointestinal bleeding No uncontrolled hyperglycemia No other medical or psychiatric condition or social situation that would preclude study compliance No other uncontrolled illness Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3-4 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics No prior immunization with gp100:209-217(210M) peptide Chemotherapy See Disease Characteristics More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy More than 2 weeks since prior steroid therapy except replacement steroids or inhaled steroids No concurrent corticosteroids except replacement steroids No concurrent dexamethasone Radiotherapy See Disease Characteristics More than 2 weeks since prior radiotherapy Surgery See Disease Characteristics Recovered from prior surgery Other No other concurrent investigational agents No other concurrent anticancer therapy
Sites / Locations
- Providence Cancer Center at Providence Portland Medical Center