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Biological Therapy in Treating Patients With Metastatic Melanoma

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00002786
Collaborator
National Cancer Institute (NCI) (NIH)
20
Enrollment
1
Location
125
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: Phase I/II 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/Phase 2

Detailed Description

OBJECTIVES:

  • Assess the safety and toxicity of cellular adoptive immunotherapy using autologous CD8+ antigen-specific T-cell clones in patients with metastatic melanoma.

  • Estimate the duration of in vivo persistence of adoptively transferred CD8+ antigen-specific cytotoxic T-cell clones in these patients.

  • Evaluate the antitumor effects of CD8+ antigen-specific T-cell clones in these patients.

OUTLINE: Autologous peripheral blood mononuclear cells are harvested and then CD8+ cytotoxic T-lymphocyte (CTL) clones targeting melanosomal antigens are generated ex vivo. Patients receive cellular adoptive immunotherapy comprising autologous CD8+ CTL clones over 30 minutes on day 1. Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-3. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for approximately 1 year after the last infusion.

PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Primary Purpose:
Treatment
Official Title:
PHASE I STUDY TO EVALUATE THE SAFETY OF CELLULAR ADOPTIVE IMMUNOTHERAPY USING GENETICALLY MODIFIED AND UNMODIFIED AUTOLOGOUS CD8+ TYROSINASE-SPECIFIC T CELLS FOR PATIENTS WITH METASTATIC MELANOMA
Study Start Date :
Oct 1, 1995
Actual Study Completion Date :
Mar 1, 2006

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:

    • Histopathologically proven metastatic melanoma

    • No CNS metastases

    • HLA-A2 positive

    • Bidimensionally measurable disease by palpation on clinical exam or radiographic imaging (x-ray, CT scan, or MRI)

    • Surgically accessible site for tumor cell procurement (skin, subcutaneous nodule, or superficial node) and patient clinically eligible for such surgery

    PATIENT CHARACTERISTICS:

    Age

    • 18 to 75

    Performance status

    • Karnofsky 80-100%

    Life expectancy

    • More than 16 weeks

    Hematopoietic

    • WBC greater than 4,000/mm^3

    • Absolute neutrophil count greater than 2,000/mm^3

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

    • Hematocrit greater than 30%

    Hepatic

    • Bilirubin no greater than 1.6 mg/dL

    • SGOT no greater than 150 IU (or no greater than 3 times normal)

    • Prothrombin time no greater than 1.5 times control

    Renal

    • Creatinine no greater than 2.0 mg/dL

    • Calcium no greater than 12 mg/dL

    Cardiovascular

    • No congestive heart failure

    • No clinically significant hypotension

    • No symptoms of coronary artery disease

    • No arrhythmia on EKG requiring drug therapy

    Pulmonary

    • No severe chronic obstructive pulmonary disease

    • FEV_1 at least 1.0 L

    • DLCO at least 45% of predicted

    Other

    • No active infection or oral temperature greater than 38.2 degrees C within 72 hours of study

    • No systemic infection requiring chronic maintenance or suppressive therapy

    • HIV negative

    • No history of seizures

    • No retinitis or choroiditis

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use adequate contraception

    • Peripheral blood samples available weekly for 4 consecutive weeks

    PRIOR CONCURRENT THERAPY:

    Biologic therapy

    • At least 4 weeks since other prior immunotherapy

    Chemotherapy

    • 1 or 2 courses of cytoreductive chemotherapy allowed for bulky disease

    • At least 4 weeks since prior standard or investigational chemotherapy

    Endocrine therapy

    • At least 4 weeks since prior steroid therapy

    Radiotherapy

    • At least 4 weeks since prior radiotherapy

    Surgery

    • Not specified

    Other

    • At least 4 weeks since other prior investigational drug therapy and recovered

    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:
    NCT00002786
    Other Study ID Numbers:
    • 1017.01
    • FHCRC-1017.01
    • NCI-V96-0920
    • CDR0000064846
    • NCT00029419
    First Posted:
    May 26, 2003
    Last Update Posted:
    May 10, 2010
    Last Verified:
    May 1, 2010
    Keywords provided by , ,
    stage IV melanoma
    recurrent melanoma
    Additional relevant MeSH terms:
    Melanoma
    Aldesleukin

    Study Results

    No Results Posted as of May 10, 2010