Vaccine Therapy in Treating Patients With Unresected Stage III or Stage IV 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 confirmed primary cutaneous or unknown primary melanoma, including 1 of the following stages: Stage IIIB or IIIC disease Unresected, in-transit lymph node metastases (N2c or N3) Stage IV disease Distant skin, subcutaneous, lymph node, or pulmonary metastases (M1a or M1b) No cerebral, bone, or other visceral metastases At least 1 measurable or evaluable lesion Small-volume multiple cutaneous deposits allowed Progressive disease, as defined by 1 of the following criteria: At least 20% increase in size in ≥ 1 measurable or evaluable lesion Appearance of ≥ 1 new lesion since or during last treatment (if applicable) AND within the past 3 months PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy At least 6 months Hematopoietic WBC ≥ 3,000/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10.0 g/dL (transfusion allowed) Hepatic SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) Lactic dehydrogenase normal No active hepatitis B or C infection Renal Creatinine ≤ 1.5 times ULN Immunologic No history of autoimmune disease Vitiligo allowed No history of immunodeficiency syndrome No active bacterial, viral, or fungal infection within the past 72 hours HIV-1 or -2 negative Human T-cell lymphotrophic virus-I or -II negative Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No contraindication to apheresis No other significant medical or surgical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy No prior vaccine therapy with ≥ 1 melanoma antigen or peptide More than 4 weeks since prior biologic therapy Chemotherapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy No concurrent chronic systemic corticosteroids Radiotherapy More than 4 weeks since prior radiotherapy Surgery Not specified Other More than 4 weeks since prior investigational products More than 4 weeks since prior chronic systemic immunosuppressive treatment No concurrent medication or treatment regimen that would prelude study participation No other concurrent anticancer treatment No other concurrent immunosuppressive treatment
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA