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Biological Therapy in Treating Patients With Metastatic Melanoma

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00045149
Collaborator
National Cancer Institute (NCI) (NIH)
1
Location
32
Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to stimulate the immune system and stop cancer cells from growing. Treating a person's white blood cells in the laboratory and then reinfusing them may cause a stronger immune response and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic melanoma.

Condition or Disease Intervention/Treatment Phase
  • Biological: aldesleukin
  • Biological: therapeutic tumor infiltrating lymphocytes
 Phase 1

Detailed Description

OBJECTIVES:

Primary

  • Determine the safety and toxicity of cellular adoptive immunotherapy comprising autologous CD8+ cytotoxic T-lymphocyte clones targeting cancer-testis antigens in patients with metastatic melanoma.

  • Determine the duration of in vivo persistence of this therapy in these patients.

Secondary

  • Evaluate the antitumor effects of this therapy in these patients.

OUTLINE: Patients undergo leukapheresis to obtain peripheral blood mononuclear cells and then CD8+ cytotoxic T-lymphocyte (CTL) clones are generated ex vivo. Patients receive cellular adoptive immunotherapy comprising autologous CD8+ CTL clones targeting cancer testis antigens IV over 30 minutes on day 1. Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-4. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who demonstrate a clinical response after completion of the fourth course are eligible to receive additional T-cell infusions.

Patients are followed for 9 months.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.

Study Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen Specific T Cell Clones Targeting Cancer Testis Antigens for Patients With Metastatic Melanoma
Study Start Date :
Oct 1, 2002
Actual Study Completion Date :
Jun 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically confirmed metastatic melanoma

    • Stage IV disease

    • HLA-A1, -A2, and -A3 positive

    • MAGE-1 or -3 positive by histology

    • Bidimensionally measurable disease by palpation on clinical examination, x-ray, or CT scan

    • No CNS metastases

    PATIENT CHARACTERISTICS:

    Age

    • 18 to 75

    Performance status

    • Karnofsky 80-100%

    Life expectancy

    • More than 6 months

    Hematopoietic

    • Not specified

    Hepatic

    • Bilirubin ≤ 1.6 mg/dL

    • SGOT ≤ 3 times upper limit of normal

    • PT ≤ 1.5 times control

    Renal

    • Creatinine ≤ 2.0 mg/dL

    • Calcium ≤ 12 mg/dL

    Cardiovascular

    • No congestive heart failure

    • No clinically significant hypotension

    • No symptoms of coronary artery disease

    • No cardiac arrhythmias on electrocardiogram requiring drug therapy

    • Patients with prior cardiovascular disease or the presence of any of the above abnormalities undergo a cardiac evaluation, which may include a stress test and/or echocardiogram

    Pulmonary

    • No clinically significant pulmonary dysfunction by medical history or physical examination

    • FEV_1 ≥ 60% of normal

    • DLCO ≥ 55% (corrected for hemoglobin)

    Other

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • No retinitis or choroiditis

    • No active infections or oral temperature greater than 38.2 degrees Celsius within the past 72 hours

    • No systemic infection requiring chronic maintenance or suppressive therapy

    PRIOR CONCURRENT THERAPY:

    Biologic therapy

    • No other concurrent immunotherapy (e.g., other interleukins, interferons, melanoma vaccines, intravenous immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer cell therapy)

    Chemotherapy

    • At least 3 weeks since prior standard or experimental chemotherapy

    • 1-2 courses of prior cytoreductive chemotherapy for bulky disease allowed

    Endocrine therapy

    • No concurrent systemic steroids (except for toxicity management)

    Radiotherapy

    • At least 3 weeks since prior radiotherapy

    Surgery

    • Not specified

    Other

    • At least 3 weeks since prior immunosuppressive therapy

    • No concurrent pentoxifylline

    • No other concurrent investigational agents

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109-1024

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Cassian Yee, MD, Fred Hutchinson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00045149
    Other Study ID Numbers:
    • 1588.00
    • FHCRC-1588.00
    • NCI-H02-0091
    • CDR0000256451
    • NCT00029432
    First Posted:
    May 28, 2003
    Last Update Posted:
    May 7, 2010
    Last Verified:
    May 1, 2010
    Keywords provided by , ,
    recurrent melanoma
    stage IV melanoma
    Additional relevant MeSH terms:
    Melanoma
    Aldesleukin

    Study Results

    No Results Posted as of May 7, 2010