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CompletedNCT00019383Updated Jun 20, 2013

Vaccine Therapy in Treating Patients With Recurrent or Refractory Metastatic Melanoma

A Phase 2 interventional study of aldesleukin and incomplete Freund's adjuvant in Melanoma (Skin), sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2013-06-20.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Ages
16 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Melanoma (Skin)

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Keywords

  • recurrent melanoma
03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

Browse Melanoma studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment

Interventions

  • Biologicalaldesleukin
  • Biologicalincomplete Freund's adjuvant
  • Biologicalsargramostim
  • Biologicaltyrosinase peptide
  • Biologicaltyrosinase-related protein-1
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Study locations

1 site
  • Surgery Branch
    Bethesda, Maryland 20892, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00019383
Lead sponsor
National Cancer Institute (NCI)
First posted
Aug 7, 2003
Start date
Jan 1998
Completion
Jun 2003
Last update
Jun 20, 2013

Study contacts

Steven A. Rosenberg, MD, PhD
study chair · NCI - Surgery Branch
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2003. You cannot join it, but the record below documents what was studied.

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