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Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery

Sponsor
University of Southern California (Other)
Overall Status
Completed
CT.gov ID
NCT00003274
Collaborator
National Cancer Institute (NCI) (NIH)
48
Enrollment
2
Locations
56
Duration (Months)
24
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known what preparation of vaccine therapy is most effective for treating melanoma.

PURPOSE: Randomized phase II trial to study the effectiveness of tyrosinase/gp100 peptide vaccine in treating patients who have stage II melanoma that can be removed by surgery.

Condition or Disease Intervention/Treatment Phase
  • Biological: gp100 antigen
  • Biological: incomplete Freund's adjuvant
  • Biological: sargramostim
  • Biological: tyrosinase peptide
 Phase 2

Detailed Description

OBJECTIVES: I. Determine immune reactivity in HLA-A2 positive patients with resectable stage IIA or IIB melanoma treated with vaccine comprising tyrosinase peptide and gp100 antigen emulsified in Montanide ISA-51 (ISA-51) alone or in combination with sargramostim (GM-CSF).

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage (IIA vs IIB). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive vaccine comprising tyrosinase peptide and gp100 antigen emulsified in Montanide ISA-51 (ISA-51) alone subcutaneously (SQ) once a week on weeks 0, 2, 4, 6, 10, 14, 18, and 26. Arm II: Patients receive treatment as in arm I followed by sargramostim (GM-CSF) SQ for 5 days after each vaccination. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study within 3 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Primary Purpose:
Treatment
Official Title:
A Randomized Phase II Trial of a Vaccine Combining Tyrosinase /gp100 Peptides Emulsified With Montanide ISA 51 Alone or With a Block Co-Polymer CRL 1005 or With GM-CSF for Patients With Resected Stages IIA and IIB Melanoma Grant Application Title: MART-1/gp100 Immune Responses to a Melanoma Vaccine
Study Start Date :
Mar 1, 1998
Actual Primary Completion Date :
Sep 1, 2001
Actual Study Completion Date :
Nov 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    DISEASE CHARACTERISTICS: Histologically proven stage IIA or stage IIB resectable cutaneous melanoma rendered disease free Clinically uninvolved lymph nodes by physical examination OR Pathologically uninvolved lymph nodes or sentinel lymph nodes after either complete node dissection or selective lymphadenectomy, respectively No evidence of metastatic disease within 28 days prior to definitive surgery HLA-A2 positive

    PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Hematopoietic: No coagulation disorders No significant hematologic abnormality Hepatic: Bilirubin no greater than 2.0 mg/dL No significant liver abnormality Renal: Creatinine no greater than 2.0 mg/dL No significant kidney abnormality Cardiovascular: No major medical illness of the cardiovascular system Pulmonary: No major medical illness of the respiratory system Other: No known allergic reaction to Montanide ISA-51 or sargramostim (GM-CSF) No major systemic infections Not pregnant or nursing HIV negative Hepatitis B surface antigen negative Hepatitis C antibody negative No prior uveitis or autoimmune inflammatory eye disease No active autoimmune disease No other malignancy within past 5 years

    PRIOR CONCURRENT THERAPY: At least 1 month since prior adjuvant therapy or any other therapy for cancer Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No concurrent steroid therapy Radiotherapy: At least 1 month since prior radiotherapy Surgery: See Disease Characteristics

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033-0804
    2 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0752

    Sponsors and Collaborators

    • University of Southern California
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Jeffrey S. Weber, MD, PhD, University of Southern California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Southern California
    ClinicalTrials.gov Identifier:
    NCT00003274
    Other Study ID Numbers:
    • CDR0000066176 (10M-97-1)
    • LAC-USC-10M971
    • LAC-USC-FDR001101
    • NCI-T97-0100
    First Posted:
    Mar 22, 2004
    Last Update Posted:
    May 22, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by University of Southern California
    stage II melanoma
    Additional relevant MeSH terms:
    Melanoma
    Sargramostim
    Freund's Adjuvant

    Study Results

    No Results Posted as of May 22, 2014