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Clinical Trials/NCT00019383
NCT00019383CompletedPhase 2

Immunization of Patients With Metastatic Melanoma Using Immunodominant Peptides From the Tyrosinase Protein or Tyrosinase Related Protein-1 (TRP1)

National Cancer Institute (NCI)1 site in 1 countryStarted: January 1, 1998Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

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.

Study Design

Study Type
Interventional
Primary Purpose
Treatment

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •DISEASE CHARACTERISTICS:
  • •Histologically proven refractory metastatic melanoma
  • •Must be HLA-A1, HLA-A3, HLA-A24, or HLA-A31 positive
  • •Measurable disease
  • •PATIENT CHARACTERISTICS:
  • •16 and over
  • •Performance Status:
  • •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
  • •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
  • •Cardiovascular:
  • •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
  • •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
  • •Prior or concurrent surgery for melanoma allowed

Exclusion Criteria

  • Not provided

Investigators

Sponsor Class
Nih

Study Sites (1)

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