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3-AP and Cytarabine in Treating Patients With Hematologic Cancer

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: July 9, 2003
Last Update Posted: July 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
July 8, 2003
July 9, 2003
July 18, 2013
March 2003
September 2004   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00064090 on ClinicalTrials.gov Archive Site
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3-AP and Cytarabine in Treating Patients With Hematologic Cancer
A Phase I Study of Triapine and Cytarabine in Patients With Hematologic Malignancies

RATIONALE: Drugs used in chemotherapy such as cytarabine use different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth and may help cytarabine kill more cancer cells by making them more sensitive to the drug.

PURPOSE: Phase I trial to study the effectiveness of combining cytarabine with 3-AP in treating patients who have relapsed or refractory hematologic cancer.


  • Determine the feasibility, tolerability, and toxic effects of 3-AP in combination with cytarabine in patients with hematologic malignancies.
  • Determine the maximum tolerated dose and phase II dose of cytarabine in this regimen in these patients.
  • Determine the biological effects of 3-AP and its interaction with cytarabine in these patients.

OUTLINE: This is a pilot, dose-escalation study of cytarabine.

Patients receive 3-AP IV over 6 hours followed by cytarabine IV over 18 hours on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a response may receive an additional course as consolidation therapy.

Cohorts of 3-6 patients receive escalating doses of cytarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients receive treatment at that dose.

PROJECTED ACCRUAL: Approximately 20-25 patients will be accrued for this study.

Phase 1
Primary Purpose: Treatment
  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • Drug: cytarabine
  • Drug: triapine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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January 2008
September 2004   (Final data collection date for primary outcome measure)


  • Diagnosis of 1 of the following hematologic malignancies:

    • Acute myeloid leukemia
    • Acute lymphoblastic leukemia
    • Chronic myelogenous leukemia (CML)
    • CML in blast crisis
    • Chronic lymphocytic leukemia
    • High-risk* myelodysplastic syndromes, including the following:

      • Refractory anemia with excess blasts (RAEB)
      • RAEB in transformation
      • Chronic myelomonocytic leukemia NOTE: *High-risk myelodysplasia defined as having an International Performance Scoring System score of at least 1.5, based on adverse cytogenetics, greater than 10% blasts in marrow, and cytopenias in at least 2 lineages
  • Relapsed or refractory disease
  • Ineligible for higher priority protocols



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 2 months


  • See Disease Characteristics


  • Bilirubin no greater than 2.0 mg/dL (unless considered due to malignancy)
  • ALT or AST no greater than 3 times upper limit of normal
  • Chronic hepatitis allowed


  • Creatinine no greater than 2.0 mg/dL (unless considered due to malignancy)


  • No myocardial infarction within the past 3 months
  • No symptomatic coronary artery disease
  • No arrhythmias (other than atrial fibrillation or flutter) requiring treatment
  • No uncontrolled congestive heart failure


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Concurrent infections under active treatment with and controlled by antibiotics allowed
  • No other concurrent life-threatening illness
  • No mental deficit or psychiatric history that would preclude giving informed consent or complying with protocol


Biologic therapy

  • At least 1 week since prior growth factors, including the following:

    • Epoetin alfa
    • Filgrastim (G-CSF)
    • Sargramostim (GM-CSF)
    • Interleukin-3
    • Interleukin-11
  • No concurrent anticancer immunotherapy


  • At least 72 hours since prior hydroxyurea
  • Recovered from prior chemotherapy
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • Not specified


  • At least 2 weeks since prior radiotherapy
  • No concurrent anticancer radiotherapy


  • Not specified


  • At least 3 weeks since prior myelosuppressive cytotoxic agents (in the absence of rapidly progressing disease)
  • At least 1 week since prior nonmyelosuppressive therapy
  • No other concurrent standard or investigational therapy for the malignancy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000306465 ( Registry Identifier: PDQ (Physician Data Query) )
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Vion Pharmaceuticals
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Study Chair: Mario Sznol, MD Vion Pharmaceuticals
National Cancer Institute (NCI)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP