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Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00019487
Collaborator
(none)
1
Location
53.9
Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune response and 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: aldesleukin
  • Biological: gp209-2M antigen
  • Biological: incomplete Freund's adjuvant
 Phase 2

Detailed Description

OBJECTIVES:

  • Determine whether reinfused activated cells alone or in conjunction with high or subcutaneous dose interleukin-2 may result in clinical tumor regression in patients with metastatic melanoma who had previously failed therapy on protocols involving immunization against the gp100 molecule.

  • Determine the survival of infused cells with antitumor activity in these patients.

OUTLINE: This is a salvage regimen.

Patients undergo leukopheresis to obtain peripheral blood mononuclear cells or tumor biopsy to obtain tumor infiltrating lymphocytes (TIL). Cells are incubated in the presence of gp209-2M peptide and then harvested and cloned. Patients receive 30-minute IV infusions of these in vitro sensitized cells. Treatment repeats every 2 weeks for 2 courses. An additional cohort of 8 patients receives gp209-2M peptide in Montanide ISA-51 subcutaneously in 2 different sites followed 2 days later by the adoptive transfer of cloned lymphocytes. At 4 to 6 weeks after the treatment courses, patients with stable or regressing disease may be retreated.

Patients with disease progression after 2 courses may receive 2 additional courses of cell infusion followed by interleukin-2 (IL-2) on one of two schedules. One cohort of patients receives IL-2 by intravenous bolus over 15 minutes every 8 hours beginning on the day after cell infusion and continuing for up to 5 days of each treatment course. Another cohort receives IL-2 by daily subcutaneous injections on days 1-12 of each course of therapy. If after 12-16 patients have been treated with cloned cells alone initially and responses are inadequate, subsequent patients entered into this study are randomized to receive the cell infusion followed by IL-2 on one of the two described schedules.

Patients are followed at 4-6 weeks.

PROJECTED ACCRUAL: A total of 91 patients will be accrued for this study over 2 years.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Treatment of Patients With Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide
Study Start Date :
Nov 1, 1998
Actual Study Completion Date :
May 1, 2003

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 metastatic melanoma that has failed therapy on protocols involving immunization against the gp100 molecule

    • Measurable or evaluable metastatic disease

    • Must be HLA-A201 positive by standard HLA typing

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

    • Absolute neutrophil count greater than 1,000/mm^3

    • Platelet count greater than 100,000/mm^3

    • Hemoglobin greater than 8.0 g/dL

    Hepatic:

    • Bilirubin no greater than 2.0 mg/dL

    • ALT/AST less than 4 times upper limit of normal

    Renal:
    • Creatinine no greater than 1.6 mg/dL
    Cardiovascular:

    • For patients randomized to receive interleukin-2:

    • No major medical illnesses of the cardiovascular system

    Pulmonary:

    • For patients randomized to receive interleukin-2:

    • No major medical illnesses of the pulmonary system

    Other:

    • HIV negative

    • Hepatitis B antigen negative

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • For patients randomized to receive interleukin-2:

    • No active systemic infection

    • No other major medical illnesses of immune system

    • No coagulation disorders

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • At least 4 weeks since prior biologic therapy
    Chemotherapy:
    • At least 4 weeks since prior chemotherapy
    Endocrine therapy:
    • No concurrent steroid therapy
    Radiotherapy:
    • At least 4 weeks since prior radiotherapy
    Surgery:
    • Not specified
    Other:
    • No concurrent active treatment of brain metastases

    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

    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:
    NCT00019487
    Other Study ID Numbers:
    • CDR0000066287
    • NCI-98-C-0095
    • NCI-T98-0012
    • NCT00001694
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jun 20, 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 20, 2013