Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic 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. Identifier: NCT00019721
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : June 20, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma.

PURPOSE: Phase II trial to compare the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have metastatic melanoma that has not responded to previous therapy.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: MART-1 antigen Biological: aldesleukin Biological: gp100 antigen Biological: incomplete Freund's adjuvant Phase 2

Detailed Description:


  • Compare the efficacy of gp100:209-217(210M) peptide and MART-1:26-35(27L) peptide administered with or without high-dose interleukin-2 (IL-2) in patients with metastatic melanoma who are HLA-A0201 positive.
  • Determine the efficacy of these peptides in patients who cannot receive IL-2.
  • Compare the efficacy of IL-2 with or without these peptides in patients who need immediate treatment with IL-2.
  • Determine the efficacy of MART-1:26-35(27L) peptide in patients who have received prior gp100 antigen.
  • Compare the immunologic response experienced by patients who have received peptide, with or without IL-2, as measured by changes in T-cell precursors from before to after treatment.
  • Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a partially randomized study.

Patients are assigned to 1 of 4 treatment groups based on disease status and prior therapy.

  • Group A (eligible to receive interleukin-2 (IL-2) but not in immediate need; no prior immunization with gp100 or MART-1 antigen): Patients are randomized to 1 of 2 treatment arms.

    • Arm I: Patients receive gp100 and MART-1 peptides emulsified in Montanide ISA-51 (ISA-51) subcutaneously (SC) on day 1. (Arm I closed as of 10/30/02).
    • Arm II: Patients receive both peptides as in arm I on day 1 and high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 (for up to 12 doses). (Arm II closed as of 10/30/02).
  • Group B (ineligible to receive IL-2 due to other debilitating disease): Patients receive treatment as in group A, arm I.
  • Group C (need immediate IL-2 therapy due to extensive and rapid progression of disease): Patients receive treatment as in group A, arm II. (Group C closed as of 10/30/02).
  • Group D (prior immunization with gp100 antigen): Patients receive modified MART-1:26-35(27L) peptide emulsified in ISA-51 SC on day 1.

Treatment in all groups repeats every 3 weeks for 4 courses. Patients who achieve a minor, mixed, or partial response may receive up to 12 additional courses. Patients who achieve complete response receive 2 additional courses.

Patients are followed at 4-6 weeks.

PROJECTED ACCRUAL: A total of 103 patients (15-25 for group A, arm I; 19-33 for group A, arm II; and 15 each for groups B, C, and D) will be accrued for this study within 1 year.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Immunization of Patients With Metastatic Melanoma Using MART-1 and GP100 Peptides Modified to Increase Binding to HLA-0201
Study Start Date : April 1999
Actual Study Completion Date : June 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Information from the National Library of Medicine

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


  • Histologically confirmed metastatic melanoma that has failed standard therapy
  • Measurable disease
  • HLA-A0201 positive



  • 16 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 3 months


  • WBC at least 3,000/mm^3
  • Platelet count at least 90,000/mm^3


  • Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)
  • AST/ALT less than 3 times normal
  • Hepatitis B surface antigen negative
  • No coagulation disorder


  • Creatinine no greater than 2.0 mg/dL


  • No major cardiovascular disease
  • If cardiovascular disease or other debilitating symptoms present, may receive peptide emulsified with Montanide ISA-51 only


  • No major respiratory disease


  • Not pregnant
  • Fertile patients must use effective contraception
  • HIV negative
  • No active systemic infection
  • No autoimmune disease or immunodeficiency disease
  • No primary or secondary immunodeficiency


Biologic therapy:

  • At least 3 weeks since prior biologic therapy
  • No prior MART-1 antigen immunization


  • At least 3 weeks since prior chemotherapy

Endocrine therapy:

  • At least 3 weeks since prior endocrine therapy
  • No concurrent steroid therapy


  • At least 3 weeks since prior radiotherapy


  • Prior surgery allowed

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): NCT00019721

United States, Maryland
Surgery Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch Identifier: NCT00019721     History of Changes
Obsolete Identifiers: NCT00001808
Other Study ID Numbers: CDR0000067051
First Posted: August 7, 2003    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: August 2002

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Freund's Adjuvant
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs