Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00025181
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 22, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Brief Summary:

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combining monoclonal antibody therapy and vaccine therapy in treating patients who have stage III or stage IV melanoma that has been removed during surgery.

Condition or disease Intervention/treatment Phase
Intraocular Melanoma Melanoma (Skin) Biological: MART-1 antigen Biological: gp100 antigen Biological: incomplete Freund's adjuvant Biological: ipilimumab Biological: tyrosinase peptide Procedure: adjuvant therapy Phase 1

Detailed Description:


  • Determine the safety and adverse event profile of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody combined with tyrosinase:368-376, gp100:209-217, and MART-1:26-35 peptides emulsified in Montanide ISA-51 in patients with resected stage III or IV melanoma.
  • Determine if this regimen causes antigen-specific T-cell activation in these patients.
  • Determine the clearance profile of this regimen in these patients.
  • Assess the development of host immune response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4).

Patients receive tyrosinase:368-376, gp100:209-217, and MART-1:26-35 peptides emulsified in Montanide ISA-51 subcutaneously followed by MDX-CTLA4 IV over 90 minutes at 0, 1, 2, 3, 4, 5, 8, and 11 months in the absence of disease progression or unacceptable toxicity.

Cohorts of at least 6 patients receive escalating doses of MDX-CTLA4 until the maximum tolerated dose is determined.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter until disease progression.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Primary Purpose: Treatment
Official Title: An Open-label Study Of MDX-CTLA4 In Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Resected Stage III Or Stage IV Melanoma
Study Start Date : October 2001
Actual Primary Completion Date : January 2003
Actual Study Completion Date : June 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed completely resected stage III or IV melanoma

    • Mucosal or ocular subtypes allowed
  • HLA-A2 positive
  • Positive staining of tumor tissue with antibody HMB-45 for gp100, tyrosinase, and/or MART-1
  • Failed (or ineligible for or refusal of) interferon alfa



  • Not specified

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 12 months


  • 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%


  • Bilirubin no greater than upper limit of normal (ULN)
  • AST no greater than 1.25 times ULN
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody nonreactive


  • Creatinine less than 1.25 times ULN


  • Antinuclear antibody (ANA) negative OR
  • If ANA positive, must be:

    • Antithyroglobulin antibody negative
    • Rheumatoid factor negative
    • Anti-LKM antibody negative
    • Anti-phospholipid antibody negative
    • Anti-islet cell antibody negative
    • Anti-neutrophil cytoplasmic antibody negative
  • HIV negative
  • No autoimmune disease (e.g., uveitis or autoimmune inflammatory eye disease)
  • No active infection
  • No hypersensitivity to tyrosinase:368-376, gp100:209-217, MART-1:26-35, or Montanide ISA-51


  • 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 underlying medical condition that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • See Disease Characteristics
  • No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
  • No prior tyrosinase, gp100, or MART-1 peptide
  • No prior antitumor vaccination
  • No prior interleukin-2
  • At least 4 weeks since prior immunotherapy for melanoma


  • At least 4 weeks since prior chemotherapy for melanoma

Endocrine therapy:

  • At least 4 weeks since prior hormonal therapy for melanoma
  • At least 4 weeks since prior corticosteroids
  • No concurrent systemic or topical corticosteroids


  • At least 4 weeks since prior radiotherapy for melanoma


  • See Disease Characteristics


  • No prior cytotoxic therapy
  • At least 4 weeks since any other prior therapy for melanoma
  • Concurrent analgesics allowed if on stable dose for at least 2 weeks before study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00025181

United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Study Chair: Jeffrey S. Weber, MD, PhD University of Southern California

Responsible Party: University of Southern California Identifier: NCT00025181     History of Changes
Other Study ID Numbers: CDR0000068934 (10M-00-4)
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 22, 2014
Last Verified: May 2014

Keywords provided by University of Southern California:
iris melanoma
ciliary body and choroid melanoma, small size
ciliary body and choroid melanoma, medium/large size
extraocular extension melanoma
recurrent intraocular melanoma
stage III melanoma
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases
Freund's Adjuvant
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs