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.

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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.

View Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT00006113

Recruitment Status:

Terminated

Sponsor:

University of Southern California

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There is 1 Location for this study

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USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California, 90089, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT00006113

Recruitment Status:

Terminated

Sponsor:


University of Southern California

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