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Monoclonal Antibody With or Without gp100 Peptides Plus Montanide ISA-51 in Treating Patients With Stage IV Melanoma

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.
ClinicalTrials.gov Identifier: NCT00077532
Recruitment Status : Completed
First Posted : February 12, 2004
Last Update Posted : June 22, 2012
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:

RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop tumor cells from growing. Vaccines made from gp100 peptides may make the body build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. It is not yet known whether monoclonal antibody therapy is more effective with or without vaccine therapy in treating advanced melanoma.

PURPOSE: This randomized phase II trial is studying monoclonal antibody therapy alone to see how well it works compared to monoclonal antibody therapy, gp100 peptides, and Montanide ISA-51 in treating patients with stage IV melanoma.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 179 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Study of Intra-Patient Escalating Doses of MDX-010 Given Alone or in Combination With Two gp100 Peptides Emulsified With Montanide ISA-51 in the Treatment of Patients With Stage IV Melanoma
Study Start Date : March 2004
Actual Primary Completion Date : January 2007
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Ipilimumab

Primary Outcome Measures :
  1. Objective response (partial and complete)

Secondary Outcome Measures :
  1. Safety
  2. Immune response activity

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed stage IV melanoma
  • Clinically evaluable or measurable disease
  • No mucosal or ocular melanoma



  • 16 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL
  • Hematocrit ≥ 28%
  • WBC ≥ 2,500/mm^3


  • AST ≤ 3 times upper limit of normal (ULN)
  • Bilirubin ≤ ULN (< 3 mg/dL for patients with Gilbert's syndrome)
  • Hepatitis B surface antigen negative
  • Hepatitis C virus antibody negative


  • Creatinine < 2 mg/dL


  • HIV negative
  • No history of any of the following:

    • Inflammatory bowel disease
    • Regional enteritis
    • Connective tissue disorders (e.g., systemic lupus erythematosus)
    • Rheumatoid arthritis
    • Autoimmune inflammatory eye disease
    • Sjögren's syndrome
    • Inflammatory neurologic disorder (e.g., multiple sclerosis)
  • No active infection
  • No active autoimmune disease that may cause life-threatening symptoms or severe organ/tissue damage

    • Vitiligo, autoimmune thyroiditis, or skin rashes associated with prior therapy are allowed if patient has recovered to grade 1 or less toxicity
  • No systemic hypersensitivity to study agents

    • Prior local reaction (e.g., delayed hypersensitivity or glaucomatous reactions) to Montanide ISA-51 or gp100 injections allowed
  • No autoimmune disease requiring active therapy with any form of steroid or immunosuppressant


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No concurrent underlying medical condition that would preclude study participation
  • 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


Biologic therapy

  • No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody
  • Prior therapy with gp100 peptides or any other immunotherapy allowed


  • At least 6 weeks since prior nitrosoureas and recovered (toxicity no greater than grade 1)
  • No concurrent chemotherapy

Endocrine therapy

  • At least 4 weeks since prior steroids
  • No concurrent systemic, inhaled, optical, or topical corticosteroids


  • Not specified


  • Not specified


  • At least 3 weeks since prior systemic therapy for melanoma and recovered (toxicity no greater than grade 1)
  • No concurrent immunosuppressive agents (e.g., cyclosporine)

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 ClinicalTrials.gov identifier (NCT number): NCT00077532

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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
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Principal Investigator: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00077532    
Obsolete Identifiers: NCT00076167
Other Study ID Numbers: 040083
First Posted: February 12, 2004    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012
Keywords provided by National Institutes of Health Clinical Center (CC):
stage IV melanoma
recurrent melanoma
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Freund's Adjuvant
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs