Melanoma Clinical Trial

Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma

Summary

RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may kill more tumor cells.

PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have metastatic melanoma.

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Full Description

OBJECTIVES:

Compare the safety of melanoma peptide vaccine with or without sargramostim (GM-CSF) in patients with high-risk or metastatic melanoma.
Compare changes in peptide-specific cellular and humoral immunologic profiles in patients treated with these regimens.
Compare tumor response in patients treated with these regimens.

OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive melanoma peptide vaccine comprising tyrosinase leader injected at 2 separate sites, Melan-A ELA injected at another site, NY-ESO-1a and NY-ESO-1b combined and injected at one site, and MAGE-10.A2 injected at another site, intradermally once weekly on weeks 1-6.
Arm II: Patients receive vaccine as in arm I. Patients also receive sargramostim (GM-CSF) subcutaneously daily beginning 2 days before each vaccination and continuing for 5 days.

Treatment in both arms continues through week 6 in the absence of disease progression or unacceptable toxicity.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this study within 18 months.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed high-risk stage III or IV melanoma

Stage III disease less than 6 months after surgical resection

Completed prior interferon alfa therapy OR
Progressive disease or major adverse events during prior interferon alfa therapy

Stage III disease at least 6 months after surgical resection

Declined, failed, or completed prior standard therapy

Stage IV disease

Declined, failed, or completed prior standard therapy
HLA-A2 positive
No CNS metastases unless treated and stable

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 80-100%

Life expectancy:

At least 4 months

Hematopoietic:

Neutrophil count at least 1,500/mm3
Lymphocyte count at least 500/mm3
Platelet count at least 100,000/mm3
Hemoglobin at least 9.0 g/dL (10.0 g/dL if less than 50 kg)
No bleeding disorder

Hepatic:

Bilirubin no greater than 2.0 mg/dL
No hepatitis B or C positivity

Renal:

Creatinine no greater than 1.8 mg/dL

Cardiovascular:

No New York Heart Association class III or IV heart disease

Other:

HIV negative
No other serious illness
No serious infection requiring antibiotics
No history of immunodeficiency disease or autoimmune disease
No psychiatric or addictive disorder that would preclude study
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

See Disease Characteristics
No prior bone marrow or stem cell transplantation
At least 4 weeks since prior immunotherapy or biologic therapy
No other concurrent immunotherapy or biologic therapy

Chemotherapy:

At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
No concurrent chemotherapy

Endocrine therapy:

No concurrent systemic corticosteroids
No concurrent steroids except topical or inhalational steroids
Concurrent hormonal therapy allowed

Radiotherapy:

At least 4 weeks since prior radiotherapy

Surgery:

See Disease Characteristics
At least 4 weeks since prior surgery

Other:

At least 4 weeks since prior investigational agents
Concurrent noncytotoxic anticancer therapy allowed
No concurrent immunosuppressive therapy
No concurrent antihistamines
No concurrent non-steroidal anti-inflammatory drugs except in low doses for prevention of an acute cardiovascular event or pain control

Study is for people with:

Melanoma

Phase:

Phase 1

Study ID:

NCT00037037

Recruitment Status:

Unknown status

Sponsor:

Herbert Irving Comprehensive Cancer Center

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Study is for people with:

Melanoma

Phase:

Phase 1

Study ID:

NCT00037037

Recruitment Status:

Unknown status

Sponsor:


Herbert Irving Comprehensive Cancer Center

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