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Vaccine Therapy in Treating Patients With Metastatic Melanoma

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00019994
Collaborator
(none)
1
Location
96
Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy.

Condition or Disease Intervention/Treatment Phase
  • Biological: MART-1 antigen
  • Biological: aldesleukin
  • Biological: gp100 antigen
  • Biological: incomplete Freund's adjuvant
 Phase 2

Detailed Description

OBJECTIVES:

  • Determine the clinical response to immunization using gp100:44-59 antigen peptide plus gp100:209-217 (210M) and MART-1:26-35 (27L) antigen peptides in patients with metastatic melanoma who are HLA-DRB1*0401 and HLA-A0201 positive.

  • Determine the clinical response to immunization using gp100:44-59 antigen peptide alone in patients with metastatic melanoma who are HLA-DRB1*0401 positive but HLA-A0201 negative.

  • Determine the immunologic response in patients treated with these regimens as measured by changes in T-cell precursors from before to after treatment.

  • Evaluate the toxicity profiles of these regimens in these patients.

OUTLINE: Patients are assigned to one of three immunization groups based on HLA-A0201 status and prior gp100:209-217 (210M) antigen peptide immunization:

  • Group 1 (HLA-A0201 positive and no prior gp100:209-217 [210M] antigen peptide): Patients receive gp100:44-59 and gp100:209-217 (210M) antigen peptides emulsified together in Montanide ISA-51 (ISA-51) subcutaneously (SC) and gp100:44-59 and MART-1:26-35 (27L) antigen peptides emulsified together in ISA-51 SC.

  • Group 2 (HLA-A0201 positive and prior gp100:209-217 [210M] antigen peptide): Patients receive treatment as in group 1.

  • Group 3 (HLA-A0201 negative and no prior gp100:209-217 [210M] antigen peptide): Patients receive gp100:44-59 antigen peptide emulsified in ISA-51 SC alone.

  • All groups: Treatment repeats every 3 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients with complete response after 4 doses receive a maximum of 2 additional doses. Patients with stable disease or minor, mixed, or partial response after 4 doses receive a maximum of 12 additional doses. Patients with no response after 4 doses receive immunization with the same peptides and interleukin-2 IV over 15 minutes every 8 hours for a maximum of 12 doses beginning 1 day after each immunization.

Patients are followed at 3-4 weeks.

PROJECTED ACCRUAL: A total of 45-75 patients (15-25 per immunization group) will be accrued for this study within 2 years.

Study Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Immunization of Patients With Metastatic Melanoma Using a Class II Restricted Peptide From the GP100 Antigen and Class I Restricted Peptides From the GP100 and MART-1 Antigens
Study Start Date :
Oct 1, 1999
Actual Study Completion Date :
Oct 1, 2007

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 metastatic melanoma that has failed standard treatment

    • HLA-DRB1*0401 positive

    • Known HLA-A0201 status

    PATIENT CHARACTERISTICS:
    Age:
    • 16 and over
    Performance status:
    • ECOG 0-2
    Life expectancy:
    • More than 3 months
    Hematopoietic:

    • WBC at least 3,000/mm^3

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

    Hepatic:

    • Bilirubin no greater than 2.0 mg/dL

    • AST or ALT less than 3 times normal

    • Hepatitis B surface antigen negative

    Renal:
    • Creatinine no greater than 2.0 mg/dL
    Cardiovascular:
    • No symptomatic cardiac disease
    Immunologic:

    • No autoimmune disease

    • No primary or secondary immunodeficiency disease

    • HIV negative

    Other:

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • No active systemic infection

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:

    • No prior immunization to the entire gp100 molecule

    • At least 3 weeks since prior gp100:209-217 antigen peptide

    • At least 3 weeks since other prior biologic therapy

    Chemotherapy:
    • At least 3 weeks since prior chemotherapy
    Endocrine therapy:

    • At least 3 weeks since prior endocrine therapy

    • No concurrent steroid therapy

    Radiotherapy:
    • At least 3 weeks since prior radiotherapy
    Surgery:
    • Prior surgery for cancer allowed
    Other:
    • At least 3 weeks since any prior therapy except surgery for cancer

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda Maryland United States 20892-1182

    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

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00019994
    Other Study ID Numbers:
    • CDR0000067391
    • NCI-99-C-0159
    • NCI-T99-0079
    • NCT00001833
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jun 19, 2013
    Last Verified:
    Mar 1, 2003
    Keywords provided by , ,
    stage IV melanoma
    recurrent melanoma
    Additional relevant MeSH terms:
    Melanoma
    Aldesleukin
    Freund's Adjuvant

    Study Results

    No Results Posted as of Jun 19, 2013