Melanoma Clinical Trial
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
Summary
RATIONALE: Vaccines made from a patient's dendritic cells may make the body build an immune response to kill tumor cells. It is not yet known whether combining vaccine therapy with either gp100 antigen or the patient's tumor cells will cause a stronger immune response and kill more tumor cells.
PURPOSE: This randomized phase II trial is studying vaccine therapy and gp100 antigen to see how well they work compared to vaccine therapy and patient's tumor cells in treating patients with stage III or stage IV melanoma.
Full Description
OBJECTIVES:
Primary
Compare the tumor-specific immune response, in terms of the number of gp100-specific cytotoxic T-lymphocytes, T-cell production of interferon gamma, or T-cell proliferation in response to in vitro exposure to gp100 and tumor lysate, in patients with stage III or IV melanoma treated with autologous dendritic cells (DC) pulsed with gp100 antigen vs autologous DC fused with autologous tumor cells.
Secondary
Compare the safety and toxicity of these regimens in these patients.
Compare the therapeutic effect of these regimens in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
All patients undergo leukapheresis. Peripheral blood mononuclear cells are cultured to generate dendritic cells (DC).
Arm I: Patients undergo surgical harvesting of tumor cells for subsequent fusion. Patients receive vaccination comprising DC fused with autologous tumor cells subcutaneously on day 1. Treatment repeats every 21 days for 3 courses. Patients who achieve a partial (PR) or complete response (CR) may receive an additional 3 courses.
Arm II: Patients receive vaccination comprising DC pulsed with gp100 antigen IV on day 1. Treatment repeats every 21 days for 6 courses. Patients who achieve a PR or CR may receive an additional 6 courses.
In both arms, patients are followed monthly for 6 months.
PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this study.
Eligibility Criteria
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 squamous 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
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