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Vaccine Therapy in Treating Patients With Recurrent or Refractory Metastatic Melanoma

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00019383
Collaborator
(none)
1
Location
65
Duration (Months)

Study Details

Study Description

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
  • Biological: aldesleukin
  • Biological: incomplete Freund's adjuvant
  • Biological: sargramostim
  • Biological: tyrosinase peptide
  • Biological: tyrosinase-related protein-1
 Phase 2

Detailed Description

OBJECTIVES:

  • 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.

Study Design

Study Type:
Interventional
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 :
Jan 1, 1998
Actual Study Completion Date :
Jun 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically proven refractory metastatic melanoma

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

    • Measurable disease

    PATIENT CHARACTERISTICS:
    Age:
    • 16 and over
    Performance Status:
    • ECOG 0-1
    Life Expectancy:
    • Greater than 3 months
    Hematopoietic:

    • WBC at least 3,000/mm^3

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

    • No coagulation disorder

    Hepatic:

    • AST or ALT less than 2 times upper limit of normal

    • Bilirubin no greater than 1.6 mg/dL

    Renal:
    • Creatinine no greater than 2.0 mg/dL
    Cardiovascular:
    • No major cardiovascular disease
    Pulmonary:
    • No major respiratory disease
    Other:

    • 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

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:

    • At least 3 weeks since prior biologic therapy

    • No concurrent biologic therapy

    Chemotherapy:

    • 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

    Radiotherapy:

    • At least 3 weeks since prior radiotherapy

    • No concurrent radiotherapy

    Surgery:
    • Prior or concurrent surgery for melanoma allowed

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Surgery Branch Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Steven A. Rosenberg, MD, PhD, NCI - Surgery Branch

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00019383
    Other Study ID Numbers:
    • CDR0000065915
    • NCI-98-C-0022
    • NCI-T97-0088
    • NCT00001684
    First Posted:
    Aug 7, 2003
    Last Update Posted:
    Jun 20, 2013
    Last Verified:
    Jun 1, 2003
    Keywords provided by , ,
    recurrent melanoma
    Additional relevant MeSH terms:
    Melanoma
    Aldesleukin
    Sargramostim
    Freund's Adjuvant

    Study Results

    No Results Posted as of Jun 20, 2013