Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2006-08-31

Brief Summary

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RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining vaccine therapy with a monoclonal antibody may cause a stronger immune response and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with monoclonal antibody therapy in treating patients who have stage IV melanoma.

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Detailed Description

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OBJECTIVES:

* Determine the clinical response in patients with stage IV melanoma when treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody combined with gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51.
* Determine a safety and adverse event profile of this regimen in these patients.
* Determine improved immunologic response in patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes immediately followed by gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51 subcutaneously on days 1, 22, 43, and 64. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study within 2 years.

Conditions

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Intraocular Melanoma Melanoma (Skin)

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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gp100 antigen

Intervention Type BIOLOGICAL

incomplete Freund's adjuvant

Intervention Type BIOLOGICAL

ipilimumab

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed stage IV melanoma

* Mucosal or ocular melanoma allowed
* Clinically evaluable disease
* HLA-A\*0201 positive

PATIENT CHARACTERISTICS:

Age:

* 16 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* At least 6 months

Hematopoietic:

* WBC at least 2,500/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
* Hematocrit at least 30%

Hepatic:

* AST no greater than 3 times upper limit of normal (ULN)
* Bilirubin no greater than ULN (less than 3.0 mg/dL in patients with Gilbert's syndrome)
* Hepatitis B surface antigen negative
* Hepatitis C antibody nonreactive

Renal:

* Creatinine less than 2.0 mg/dL

Immunologic:

* Antinuclear antibody negative
* Thyroglobulin antibody normal
* Rheumatoid factor normal
* HIV negative
* No prior autoimmune disease (including uveitis and autoimmune inflammatory eye disease)
* No active infection
* No hypersensitivity to Montanide ISA-51

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
* No other underlying medical condition that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 3 weeks since prior immunotherapy for melanoma and recovered
* No prior gp100 peptides
* No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody

Chemotherapy:

* At least 3 weeks since prior chemotherapy for melanoma and recovered
* No concurrent chemotherapy

Endocrine therapy:

* At least 3 weeks since prior hormonal therapy for melanoma and recovered
* At least 4 weeks since prior systemic or topical corticosteroids
* No concurrent topical or systemic corticosteroids

Radiotherapy:

* At least 3 weeks since prior radiotherapy for melanoma and recovered

Surgery:

* Not specified

Other:

* No other concurrent immunosuppressive agents (e.g., cyclosporine and its analog)

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No