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.

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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.

View Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

6

Study ID:

NCT00334776

Recruitment Status:

Completed

Sponsor:

University of Southern California

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There are 2 Locations for this study

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USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California, 90089, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

6

Study ID:

NCT00334776

Recruitment Status:

Completed

Sponsor:


University of Southern California

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