Melanoma Clinical Trial
Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma
Summary
RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. Biological therapies such as interferon gamma and interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying giving vaccine therapy together with interferon gamma and interleukin-2 in treating patients with stage III or stage IV melanoma.
Full Description
OBJECTIVES:
Determine the clinical response rate and immune response in HLA-A2 positive patients with stage III or IV melanoma after receiving autologous dendritic cells pulsed with melanoma antigen peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) and treated ex vivo with CD40-ligand and interferon gamma, followed by interleukin-2 in vivo.
Determine the toxicities of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients undergo leukapheresis to harvest autologous dendritic cells (ADCs). Melanoma peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) are pulsed separately onto ADCs, which are also treated ex vivo with CD40-ligand, interferon gamma, interleukin-4, sargramostim (GM-CSF), and Candida albicans skin test reagent. Patients receive each melanoma peptide pulsed ADC vaccine separately via 3 successive 10 minute infusions on day 1. Patients then receive interleukin-2 subcutaneously every 12 hours on days 2-6. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, then every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 18-24 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic melanoma
Measurable disease after attempted curative surgery
Unresectable stage III or IV uveal melanoma
Metastatic mucosal melanoma
HLA-A2.1 positive
No disease progression following high dose interleukin-2 (600,000 or 720,000 IU/kg every 8 hours)
PATIENT CHARACTERISTICS:
Age:
18 and over
Performance status:
ECOG 0-1
Life expectancy:
Not specified
Hematopoietic:
WBC at least 3,000/mm^3
Platelet count at least 75,000/mm^3
Hemoglobin at least 9.0 g/dL
No coagulation disorders
Hepatic:
Bilirubin no greater than 2.0 mg/dL
Renal:
Creatinine no greater than 2.0 mg/dL
Cardiovascular:
No myocardial infarction within the past 6 months
Patients with documented or suspected coronary artery disease must undergo stress thallium test
No major cardiovascular illness
Pulmonary:
No major pulmonary illness
Immunologic:
HIV negative
Hepatitis B surface antigen negative
Hepatitis C antibody negative
No history of uveitis or autoimmune inflammatory eye disease
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No major systemic infection
No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
See Disease Characteristics
No prior MART-1:26-35, gp100:209-217, or tyrosinase:368-376 antigens
Chemotherapy:
At least 1 month since prior chemotherapy for melanoma
Endocrine therapy:
No concurrent steroid therapy
Radiotherapy:
At least 1 month since prior radiotherapy for melanoma
Surgery:
See Disease Characteristics
Other:
At least 1 month since prior adjuvant therapy for melanoma
At least 1 month since other prior therapy for melanoma
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There is 1 Location for this study
Los Angeles California, 90089, United States
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