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Status:

COMPLETED

Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Melanoma (Skin)

Eligibility:

All Genders

16+ years

Phase:

PHASE2

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase II trial is studying immunization using two different gp100 protein vaccines to comp...

Detailed Description

OBJECTIVES: Primary * Compare the clinical response in patients with metastatic melanoma immunized with recombinant gp100 protein (184V) emulsified in Montanide ISA-51 with or without gp100:209-217 ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of metastatic melanoma
  • Measurable disease
  • Progressive disease during or after prior standard treatment with or without interleukin-2
  • PATIENT CHARACTERISTICS:
  • Age
  • 16 and over
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • More than 6 months
  • Hematopoietic
  • WBC at least 3,000/mm\^3
  • Platelet count at least 90,000/mm\^3
  • Lymphocyte count greater than 500/mm\^3
  • Hepatic
  • Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)
  • ALT and AST 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 active systemic infection
  • No autoimmune disease
  • No known immunodeficiency disease
  • No known hypersensitivity to study agents
  • No form of primary or secondary immunodeficiency
  • No opportunistic infection
  • HIV negative
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • See Disease Characteristics
  • No prior gp100 peptide vaccine
  • Chemotherapy
  • More than 6 weeks since prior nitrosoureas
  • Endocrine therapy
  • No concurrent systemic steroid therapy
  • Radiotherapy
  • Not specified
  • Surgery
  • Prior recent (within the past 3 weeks) minor surgical procedures allowed
  • Other
  • Recovered from prior therapy (toxicity no greater than grade 1)
  • More than 3 weeks since prior systemic anticancer therapy
  • No other concurrent systemic anticancer therapy

Exclusion

    Key Trial Info

    Start Date :

    September 1 2003

    Trial Type :

    INTERVENTIONAL

    End Date :

    July 1 2006

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00072085

    Start Date

    September 1 2003

    End Date

    July 1 2006

    Last Update

    June 19 2013

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, United States, 20892-1182

    2

    NCI - Center for Cancer Research

    Bethesda, Maryland, United States, 20892