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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00032045

Collaborator

(none)

Location

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Intraocular Melanoma Melanoma (Skin)	Biological: gp100 antigen Biological: incomplete Freund's adjuvant Biological: ipilimumab	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label Study Of MDX-010 In Combination With gp100 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Stage IV Melanoma

Study Start Date :

Jan 1, 2002

Actual Study Completion Date :

Aug 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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