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Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00020397
Collaborator
(none)
1
Location
56
Duration (Months)

Study Details

Study Description

Brief Summary

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

PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have refractory metastatic melanoma.

Condition or Disease Intervention/Treatment Phase
  • Biological: NY-ESO-1 peptide vaccine
  • Biological: aldesleukin
 Phase 2

Detailed Description

OBJECTIVES:

  • Determine whether an immunologic response can be obtained after administration of ESO-1 peptide vaccine comprising class I , II, or both peptides in HLA-A201 or HLA-DPB104 positive patients with refractory metastatic melanoma expressing ESO-1.

  • Determine the toxicity of this vaccine in these patients.

  • Determine whether prior immunization with this vaccine results in increased clinical responsiveness in patients treated with interleukin-2.

OUTLINE: Patients are assigned to 1 of 3 groups according to HLA type.

  • Group 1 (HLA-A201 and HLA-DPB104 positive): Patients receive ESO-1 peptide vaccine comprising class I (ESO-1:157-165 [165V]) and class II (ESO-1:161-180) peptides subcutaneously once every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

  • Group 2 (HLA-A201 positive and HLA-DPB104 negative):Patients receive ESO-1 peptide vaccine as in group I comprising class I peptide only.

  • Group 3 (HLA-A201 negative and HLA-DPB104 positive):Patients receive ESO-1 peptide vaccine as in group I comprising class II peptide only.

Patients who develop disease progression discontinue vaccinations and receive high-dose interleukin (IL-2) IV over 15 minutes every 8 hours for up to 4 days (maximum of 12 doses). Treatment with IL-2 repeats every 10-14 days for 4 courses in the absence of disease progression (after at least 2 courses) or unacceptable toxicity.

Patients who have stable disease or a mixed or partial response to vaccination or IL-2 therapy may be eligible for additional vaccine therapy. Patients who have a complete response to vaccine therapy are eligible for 1 additional treatment.

Patients are followed at 3 weeks.

PROJECTED ACCRUAL: A total of 45-90 patients (15-30 per treatment group) will be accrued for this study within 1 year.

Study Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Immunization Of HLA-A*0201 or HLA-DPB1*04 Patients With Metastatic Melanoma Using Epitopes From The ESO-1 Antigen
Study Start Date :
Nov 1, 2000
Actual Study Completion Date :
Jul 1, 2005

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:

    • Diagnosis of metastatic melanoma that expresses ESO-1 antigen

    • Must have progressed during prior standard treatment

    • Measurable or evaluable disease

    • HLA-A201 or HLA-DPB104 positive

    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:

    • SGOT and SGPT less than 3 times normal

    • Bilirubin no greater than 1.6 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome)

    • Hepatitis B surface antigen negative

    Renal:
    • Creatinine no greater than 2.0 mg/dL
    Cardiovascular:

    • No cardiac ischemia*

    • No myocardial infarction*

    • No cardiac arrhythmias* NOTE: *For interleukin-2 (IL-2) administration

    Pulmonary:
    • No obstructive or restrictive pulmonary disease (for IL-2 administration)
    Immunologic:

    • No autoimmune disease

    • No active primary or secondary immunodeficiency

    • HIV negative

    • No active systemic infections

    Other:

    • Not pregnant

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • No other active major medical illness (for IL-2 administration)

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • No prior ESO-1 immunization
    Chemotherapy:
    • Recovered from any prior chemotherapy
    Endocrine therapy:
    • No concurrent systemic steroid therapy
    Radiotherapy:
    • Recovered from any prior radiotherapy
    Surgery:
    • Not specified
    Other:

    • At least 3 weeks since any prior systemic therapy for cancer

    • No other concurrent systemic therapy 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

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00020397
    Other Study ID Numbers:
    • CDR0000068403
    • NCI-01-C-0032
    • NCI-2390
    • NCT00006491
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jun 19, 2013
    Last Verified:
    Jan 1, 2005
    Keywords provided by , ,
    recurrent melanoma
    stage IV melanoma
    Additional relevant MeSH terms:
    Melanoma
    Aldesleukin

    Study Results

    No Results Posted as of Jun 19, 2013