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Compound 506U78 (NSC 686673) in Patients With Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma (NCT00003837)

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Clinical trial to study the effectiveness of 506U78 in treating patients who have relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
  • Drug: nelarabine
    Ages eligible for Study
    16 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    OBJECTIVES:

    - Provide an investigational agent, 506U78, to physicians for the management of individual patients with relapsed or refractory T-cell acute lymphoblastic (lymphocytic) leukemia or T-cell lymphoblastic lymphoma who are not candidates for entry onto ongoing research clinical trials of higher priority.

    - Evaluate the toxic effects of 506U78 when administered as a 2 hour IV infusion 3 days a week every 21 days in these patients.

    - Evaluate the antitumor efficacy of this regimen in terms of rate of complete responses in these patients.

    OUTLINE: Patients receive 506U78 over 2 hours on days 1, 3, and 5. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression.

    Patients are followed every 3 months for one year and then every 6 months until death.

    PROJECTED ACCRUAL: A minimum of 25 patients will be accrued for this study.

    7 locations

    United States (7)
    • City of Hope Comprehensive Cancer Center
      Duarte, California, United States, 91010-3000
    • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
      Tampa, Florida, United States, 33612
    • NCI - Pharmaceutical Management Branch
      Bethesda, Maryland, United States, 20892
    • Barbara Ann Karmanos Cancer Institute
      Detroit, Michigan, United States, 48201-1379
    • Mayo Clinic Cancer Center
      Rochester, Minnesota, United States, 55905
    • Case Comprehensive Cancer Center
      Cleveland, Ohio, United States, 44106-5047
    • Abramson Cancer Center of the University of Pennsylvania
      Philadelphia, Pennsylvania, United States, 19104-4283
    Status:
    completed
    Type:
    Interventional
    Phase:
    -
    Start:
    31 August, 1999
    Updated:
    17 June, 2013
    Participants:
    25
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