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Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

Sponsor
University of Virginia (Other)
Overall Status
Completed
CT.gov ID
NCT00089206
Collaborator
National Cancer Institute (NCI) (NIH)
7
Enrollment
1
Location

Study Details

Study Description

Brief Summary

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

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.

Condition or Disease Intervention/Treatment Phase
  • Biological: incomplete Freund's adjuvant
  • Biological: multi-epitope melanoma peptide vaccine
  • Biological: sargramostim
 Phase 2

Detailed Description

OBJECTIVES:
  • Determine the antitumor immune response in patients with unresectable stage III or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51.

OUTLINE: Patients receive vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, 15, 29, 36, and 43. Patients undergo removal of the lymph node draining the vaccination site on day 22 to assess immune response.

PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
7 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Vaccination With Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant in Patients With Advanced Melanoma
Study Start Date :
Aug 1, 2002
Actual Primary Completion Date :
Nov 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

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

    • Diagnosis of melanoma

    • Unresectable stage III or IV disease

    • Mucosal or ocular disease allowed

    • Positive HLA-A1, -A2, or -A3 expression

    PATIENT CHARACTERISTICS:

    Age

    • 12 and over

    Performance status

    • ECOG 0-1

    Life expectancy

    • Not specified

    Hematopoietic

    • Absolute neutrophil count > 1,000/mm^3

    • Platelet count > 100,000/mm^3

    • Hemoglobin > 9 g/dL

    Hepatic

    • Liver function tests ≤ 2.5 times upper limit of normal (ULN)

    Renal

    • Creatinine ≤ 1.5 times ULN

    Cardiovascular

    • No New York Heart Association class III or IV heart disease

    Other

    • Weight ≥ 100 pounds

    • Not pregnant or nursing

    • No other malignancy within the past 5 years except squamous cell or basal cell skin cancer without known metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix

    PRIOR CONCURRENT THERAPY:

    Biologic therapy

    • No prior vaccination with any of the peptides used in this protocol

    • More than 1 year since prior melanoma vaccine therapy

    • More than 4 weeks since prior immunotherapy

    • More than 4 weeks since prior growth factors

    • More than 4 weeks since prior allergy shots

    Chemotherapy

    • More than 4 weeks since prior chemotherapy

    Endocrine therapy

    • More than 4 weeks since prior steroid therapy

    Radiotherapy

    • More than 4 weeks since prior radiotherapy

    Surgery

    • Prior tumor resection allowed

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Center at the University of Virginia Charlottesville Virginia United States 22908

    Sponsors and Collaborators

    • University of Virginia
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Craig L. Slingluff, MD, University of Virginia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Craig L Slingluff, Jr, Professor of Surgery, University of Virginia
    ClinicalTrials.gov Identifier:
    NCT00089206
    Other Study ID Numbers:
    • 10049
    • UVACC-MEL-42
    • UVACC-24802
    First Posted:
    Aug 5, 2004
    Last Update Posted:
    Dec 19, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by Craig L Slingluff, Jr, Professor of Surgery, University of Virginia
    stage III melanoma
    stage IV melanoma
    recurrent melanoma
    recurrent intraocular melanoma
    iris melanoma
    extraocular extension melanoma
    ciliary body and choroid melanoma, medium/large size
    Additional relevant MeSH terms:
    Melanoma
    Sargramostim
    Freund's Adjuvant

    Study Results

    No Results Posted as of Dec 19, 2014