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Vaccine Therapy in Treating Patients With Recurrent or Refractory 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: NCT00019383
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. Giving the vaccine with interleukin-2 or sargramostim may help kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of peptide vaccine with or without adjuvant interleukin-2 or sargramostim in treating patients who have recurrent or refractory metastatic melanoma.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: aldesleukin Biological: incomplete Freund's adjuvant Biological: sargramostim Biological: tyrosinase peptide Biological: tyrosinase-related protein-1 Phase 2

Detailed Description:


  • Determine whether patients with refractory metastatic melanoma undergo partial or complete response to peptides specific to their HLA-antigen, either alone or when combined with 1 of 3 adjuvants.
  • Evaluate the immunologic response to the peptide alone or when combined with 1 of 3 adjuvants in these patients.

OUTLINE: Patients are stratified by HLA status (A1 vs A3 vs A24 vs A31).

Patients are assigned to 1 of 4 vaccine groups:

  • Group 1 (HLA-A1 positive): Patients receive tyrosinase:240-251.
  • Group 2 (HLA-A3 positive): Patients receive gp100:17-25. (closed to accrual 5/17/2000)
  • Group 3 (HLA-A24 positive): Patients receive tyrosinase:206-214.
  • Group 4 (HLA-A31 positive): Patients receive tyrosinase related protein-1. Each peptide vaccine is separately emulsified in Montanide ISA-51 and administered subcutaneously into the thigh. Patients are treated with peptide vaccine alone or combined with 1 of 3 possible adjuvants (interleukin-2 (IL-2) IV, IL-2 delayed IV, or sargramostim (GM-CSF) SQ) depending on the time of entry into study and response to treatment.

At least 4 to 6 patients are accrued for the peptide alone cohort before beginning accrual on the other cohorts. Any patient who experiences unacceptable toxicity due to adjuvant therapy is taken off study. If a second patient develops unacceptable toxicity, that schedule of peptide administration is discontinued.

Patients exhibiting stable, minor, mixed, or partial response may receive up to 12 additional courses.

Patients are followed for 4-6 weeks.

PROJECTED ACCRUAL: A maximum of 457 patients will be accrued for this study over 3.5 years.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Immunization of Patients With Metastatic Melanoma Using Immunodominant Peptides From the Tyrosinase Protein or Tyrosinase Related Protein-1 (TRP1)
Study Start Date : January 1998
Actual Study Completion Date : June 2003

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 proven refractory metastatic melanoma

    • Must be HLA-A1, HLA-A3, HLA-A24, or HLA-A31 positive
  • Measurable disease



  • 16 and over

Performance Status:

  • ECOG 0-1

Life Expectancy:

  • Greater than 3 months


  • WBC at least 3,000/mm^3
  • Platelet count at least 90,000/mm^3
  • No coagulation disorder


  • AST or ALT less than 2 times upper limit of normal
  • Bilirubin no greater than 1.6 mg/dL


  • Creatinine no greater than 2.0 mg/dL


  • No major cardiovascular disease


  • No major respiratory disease


  • Not pregnant
  • Fertile patients must use effective contraception
  • HIV negative
  • Hepatitis B surface antigen negative
  • No known allergy to Montanide ISA-51
  • No active systemic infection
  • No immunodeficiency disease


Biologic therapy:

  • At least 3 weeks since prior biologic therapy
  • No concurrent biologic therapy


  • At least 3 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy:

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


  • At least 3 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • Prior or concurrent surgery for melanoma 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): NCT00019383

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United States, Maryland
Surgery Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch

Layout table for additonal information Identifier: NCT00019383     History of Changes
Obsolete Identifiers: NCT00001684
Other Study ID Numbers: CDR0000065915
First Posted: August 7, 2003    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: June 2003
Keywords provided by National Cancer Institute (NCI):
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
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic