Last updated on February 2009

Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Melanoma (Skin)
  • Age: - 100 Years
  • Gender: Male or Female
  • Other:
    DISEASE CHARACTERISTICS:
    Histologically confirmed cutaneous melanoma
    Stage III or IV disease
    Recurrent or de novo stage III disease allowed if disease is unresectable and no
    definitive treatment is available
    gp100- and HLA-A201-positive
    Surgically accessible tumor, defined by 1 of the following:
    Pulmonary lesions approachable by thoracoscopic procedure
    Skin or superficial soft tissue or lymph node lesions amenable to resection
    under local anesthesia
    Malignant ascites or pleural effusion
    Measurable disease in addition to surgically accessible tumor > 2.0 cm
    No CNS metastases
    No mucosal or ocular melanoma
    PATIENT CHARACTERISTICS:
    Age
    Any age
    Performance status
    ECOG 0-1
    Life expectancy
    More than 3 months
    Hematopoietic
    WBC > 3,000/mm^3
    Platelet count > 75,000/mm^3
    Hepatic
    Bilirubin < 2.0 mg/dL
    Renal
    Creatinine < 2.0 mg/dL
    Immunologic
    No active infection requiring treatment
    No clinically significant autoimmune disorder
    No immune deficiency disorder
    HIV negative
    Other
    Antecubital vein accessible for leukapheresis
    No other malignancy within the past 5 years except nonmelanoma skin cancer or
    quamous cell carcinoma in situ of the cervix
    No pre-existing comorbid disease that would preclude study compliance
    Not pregnant or nursing
    Negative pregnancy test
    Fertile patients must use effective barrier contraception
    PRIOR CONCURRENT THERAPY:
    Biologic therapy
    No prior melanoma vaccine therapy
    More than 6 weeks since prior immunotherapy
    Chemotherapy
    No prior chemotherapy for metastatic melanoma
    Endocrine therapy
    No concurrent corticosteroids
    Radiotherapy
    More than 6 weeks since prior radiotherapy
    Surgery
    Not specified
    Other
    No concurrent systemic immunosuppressive therapy

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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