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Fludarabine Followed By Adoptive Immunotherapy in Treating Patients With Stage IV Melanoma

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00317759
Collaborator
National Cancer Institute (NCI) (NIH)
12
Enrollment
1
Location
65.1
Duration (Months)
0.2
Patients Per Site Per Month

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. Fludarabine may help the immune system kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of fludarabine followed by cellular adoptive immunotherapy in treating patients who have metastatic melanoma.

Condition or Disease Intervention/Treatment Phase
  • Biological: therapeutic autologous lymphocytes
  • Drug: fludarabine phosphate
 Phase 1

Detailed Description

OBJECTIVES:

Primary

  • Determine the safety and toxicity of adoptive immunotherapy comprising autologous CD8+ antigen-specific cytotoxic T-lymphocyte (CTL) clones after fludarabine in patients with stage IV melanoma.

  • Determine the duration of in vivo persistence of these CTL clones in these patients.

Secondary

  • Determine the antitumor effect of this regimen in these patients.

OUTLINE: This is an open-label, nonrandomized study.

Patients undergo leukapheresis or weekly phlebotomy for the collection of peripheral blood mononuclear cells from which autologous antigen-specific CD8+ cytotoxic T-lymphocyte (CTL) clones are generated. Patients receive autologous antigen-specific CD8+ CTL clones IV over 30-60 minutes on days 0 and 21 in the absence of rapid disease progression or unacceptable toxicity. Patients also receive fludarabine IV once daily on days 14-18.

Patients are followed for up to 1 year.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 3 years.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
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 Following Fludarabine Lymphodepletion for Patients With Metastatic Melanoma
Study Start Date :
May 1, 2003
Actual Study Completion Date :
Oct 1, 2008

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-A2 or -A3-expressing disease

    • Bidimensionally measurable residual disease by palpation or radiographic imaging (e.g., x-ray or CT scan)

    • No CNS metastases

    • Previously treated CNS involvement allowed provided there is no evidence of CNS disease at least 2 months after completion of therapy

    PATIENT CHARACTERISTICS:

    Age

    • 18 to 75

    Performance status

    • Karnofsky 80-100%

    Life expectancy

    • More than 6 months

    Hematopoietic

    • Platelet count > 100,000/mm^3

    • Absolute neutrophil count > 2,000/mm^3

    Hepatic

    • SGOT no greater than 3 times upper limit of normal

    • Bilirubin no greater than 1.6 mg/dL

    • INR no greater than 1.5 times normal

    Renal

    • Creatinine no greater than 2.0 mg/dL OR

    • Creatinine clearance at least 60 mL/min

    Cardiovascular

    • No congestive heart failure

    • No clinically significant hypotension

    • No symptoms of coronary artery disease

    • No cardiac arrhythmia by EKG requiring drug therapy

    Pulmonary

    • No clinically significant pulmonary dysfunction

    • FEV_1 at least 1.0 L*

    • DLCO at least 45%* NOTE: *For patients with a history of pulmonary dysfunction

    Immunologic

    • No active infection

    • No oral temperature greater than 38.2°C within the past 48 hours

    • No systemic infection requiring chronic maintenance or suppressive therapy

    Other

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY:

    Biologic therapy

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

    Chemotherapy

    • At least 3 weeks since prior chemotherapy (standard or experimental)

    Endocrine therapy

    • No concurrent steroids

    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

    • Principal Investigator: Cassian Yee, MD, Fred Hutchinson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00317759
    Other Study ID Numbers:
    • 1796.00
    • FHCRC-1796.00
    • CDR0000327817
    First Posted:
    Apr 25, 2006
    Last Update Posted:
    Oct 1, 2015
    Last Verified:
    May 1, 2010
    Keywords provided by , ,
    stage IV melanoma
    recurrent melanoma
    Additional relevant MeSH terms:
    Melanoma
    Fludarabine
    Fludarabine phosphate

    Study Results

    No Results Posted as of Oct 1, 2015