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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
NCT00019214
Collaborator
(none)
1
Location
111
Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Vaccines made from white blood cells treated with antigens may make the body build an immune response to kill melanoma cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may kill more melanoma cells.

PURPOSE: This phase I/II trial is studying the side effects and how well giving vaccine therapy and interleukin-2 works compared to vaccine therapy alone in treating patients with metastatic melanoma that has not responded to previous therapy.

Condition or Disease Intervention/Treatment Phase
  • Biological: MART-1 antigen
  • Biological: aldesleukin
  • Biological: gp100 antigen
 Phase 1/Phase 2

Detailed Description

OBJECTIVES:
  • Evaluate the toxicity, immunologic reactivity, and possible therapeutic efficacy of immunization with dendritic cells presenting the MART-1 and gp100 melanoma antigens with or without interleukin-2 in patients with metastatic melanoma.

OUTLINE: This is a dose-escalation study of dendritic cells pulsed with MART-1 and gp100 antigens.

Patients receive vaccinations with dendritic cells pulsed with MART-1 and gp100 antigens, either intralymphatically every 4 weeks for 2 doses, or IV every 3 weeks for 4 doses. Some patients also receive interleukin-2 subcutaneously or IV, over 3-5 days, beginning 24 hours after immunization.

Cohorts of 2-9 patients receive escalating doses of pulsed dendritic cells IV until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Subsequent cohorts receive cells with or without interleukin-2. One cohort may expand to 15 patients to determine the accuracy of immunologic response to the vaccine.

One cohort of 11 patients receives cells intralymphatically without interleukin-2 every 3-4 weeks for 2 courses. Patients with stable disease or who achieve minor, mixed, or partial response may be retreated.

Patients with stable or responding disease undergo a second course of vaccination. Patients who completed treatment with vaccine alone and have stable disease, progressive disease, disease progression after a response, or a partial response with no further improvement may receive 2 additional courses.

PROJECTED ACCRUAL: A total of 10-42 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase I/II Study in Patients With Metastatic Melanoma of Immunization With Dendritic Cells Presenting Epitopes Derived From The Melanoma Associated Antigens MART-1 and gp 100
Study Start Date :
Apr 1, 1997
Actual Study Completion Date :
Jul 1, 2006

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 confirmed metastatic melanoma that has failed standard effective therapy

    • Measurable or evaluable disease

    • HLA-A2 positive

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

    • WBC greater than 3,000/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

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

    • Negative hepatitis B surface antigen

    • No coagulation disorder

    Renal:

    • Creatinine no greater than 1.6 mg/dL OR

    • Creatinine clearance greater than 75 mL/min

    Cardiovascular:
    • No major cardiovascular disease
    Pulmonary:
    • No major respiratory disease
    Other:

    • No major immunological disease

    • No penicillin allergy

    • HIV negative

    • No active systemic infection

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY:

    Biologic therapy

    • Not specified

    Chemotherapy

    • Not specified

    Endocrine therapy

    • At least 4 weeks since prior steroid therapy and recovered

    Radiotherapy

    • Not specified

    Surgery

    • Not specified

    Other

    • More than 4 weeks since any other prior therapy and recovered

    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: James C. Yang, MD, NCI - Surgery Branch

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00019214
    Other Study ID Numbers:
    • CDR0000065234
    • NCI-97-C-0046
    • NCI-97-C-0019
    • NCI-T96-0046N
    • NCT00001558
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jun 20, 2013
    Last Verified:
    Jan 1, 2005
    Keywords provided by , ,
    recurrent melanoma
    Additional relevant MeSH terms:
    Melanoma
    Aldesleukin

    Study Results

    No Results Posted as of Jun 20, 2013