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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


Phase 2
16 Years
N/A
Not Enrolling
Both
Intraocular Melanoma, Melanoma (Skin)

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Trial Information

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


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.

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)

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Steven A. Rosenberg, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Surgery Branch

Authority:

United States: Federal Government

Study ID:

CDR0000069251

NCT ID:

NCT00032045

Start Date:

January 2002

Completion Date:

August 2006

Related Keywords:

  • Intraocular Melanoma
  • Melanoma (Skin)
  • iris melanoma
  • ciliary body and choroid melanoma, small size
  • ciliary body and choroid melanoma, medium/large size
  • extraocular extension melanoma
  • recurrent intraocular melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma
  • Uveal Neoplasms

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182