Melanoma Clinical Trial
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Summary
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.
Full Description
OBJECTIVES:
Primary
Determine clinical response in HLA-A *0201-positive patients with metastatic melanoma treated with an intradermally administered vaccine comprising autologous dendritic cells pulsed with MART-1, gp100, and tyrosinase peptides and matured with a cytokine cocktail.
Secondary
Determine immunologic response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients undergo apheresis to collect dendritic cells (DC). Autologous DC are pulsed ex vivo with tumor antigen peptides derived from MART-1: 26-35 (27L), gp100: 209-217 (210M), and tyrosinase: 368-376 (370D) and matured with a cytokine cocktail comprising interleukin (IL)-4, IL-6, IL-1β, sargramostim (GM-CSF), tumor necrosis factor-α, and prostaglandin E2.
Patients receive 12 intradermal injections of DC vaccine over 30 minutes on days 1, 8, 22, and 36. Treatment repeats every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically until disease progression.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of melanoma
Metastatic disease
The following melanoma subtypes are eligible:
Unresectable, stage III-IV uveal melanoma
Metastatic mucosal melanoma
Measurable disease after attempted curative surgical therapy
Tumor tissue must be available for immunohistochemical staining
Positive for ≥ 1 of the following peptides:
MART-1: 26-35 (27L)
gp100: 209-217 (210M)
Tyrosinase: 368-376 (370D)
HLA-A *0201 positive by DNA polymerase chain reaction assay
PATIENT CHARACTERISTICS:
ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
Creatinine ≤ 2.0 mg/dL
Bilirubin ≤ 2.0 mg/dL
WBC ≥ 3,000/mm^3
Platelet count ≥ 75,000/mm^3
Hemoglobin ≥ 9.0 g/dL
No major systemic infections
No coagulation disorders
No major medical illness of the cardiovascular or respiratory system
No myocardial infarction within the past 6 months
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No known HIV positivity
No know positivity for hepatitis B surface antigen or hepatitis C antibody
No prior uveitis or autoimmune inflammatory eye disease
No other prior malignancy except cervical carcinoma in situ or basal cell skin cancer unless patient was curatively treated > 5 years ago and has no detectable disease
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No more than 1 prior cytotoxic chemotherapy agent or regimen
Prior biologic or antiangiogenic therapies allowed
More than 1 month since prior and no concurrent radiotherapy, chemotherapy, adjuvant therapy, or any other therapy for melanoma
No prior MART-1: 26-35 (27L), gp100: 209-217 (210M), or tyrosinase: 368-376 (370D) peptides
No concurrent steroid therapy
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There are 2 Locations for this study
Los Angeles California, 90089, United States
Ann Arbor Michigan, 48109, United States
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