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Status:

COMPLETED

3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Accelerated Phase Chronic Myelogenous Leukemia

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

Drugs used in chemotherapy, such as cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may help cytarabine kill more cancer cells by making them mo...

Detailed Description

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of 3-AP (Triapine) administered with high-dose cytarabine in patients with advanced hematologic malignancies. SECONDARY OBJECTIVES: I. De...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically confirmed diagnosis of 1 of the following hematologic malignancies:
  • Relapsed or refractory acute myeloid leukemia (AML)
  • Relapsed or refractory acute lymphoblastic leukemia
  • Secondary AML, including AML arising from antecedent hematologic diseases, such as myelodysplastic syndromes or myeloproliferative disorders OR therapy-related AML
  • Chronic myeloid leukemia in accelerated or blast phase
  • Refractory to standard therapy or no standard therapy exists
  • No known brain metastases
  • Performance status - CALGB 0-2
  • Performance status - Karnofsky 60-100%
  • No G6PD deficiency
  • Bilirubin \< 2.0 mg/dL (unless due to Gilbert's syndrome)
  • AST and ALT \< 2.5 times upper limit of normal (ULN)
  • Creatinine \< 1.5 times ULN
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No pulmonary disease requiring oxygen
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior allergic reactions attributed to compounds of similar chemical or biological composition to study drugs
  • No neuropathy
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other concurrent uncontrolled illness
  • No concurrent biologic agents
  • At least 72 hours since prior hydroxyurea
  • At least 2 weeks since other prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
  • No other concurrent chemotherapy
  • At least 2 weeks since prior radiotherapy
  • No concurrent radiotherapy
  • Recovered from all prior therapy
  • At least 4 weeks since prior investigational agents
  • No other concurrent investigational therapy
  • No other concurrent anticancer therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients

Exclusion

    Key Trial Info

    Start Date :

    January 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    48 Patients enrolled

    Trial Details

    Trial ID

    NCT00077181

    Start Date

    January 1 2004

    Last Update

    January 24 2013

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, United States, 60637-1470