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A Phase I Study of Triapine and Cytarabine in Patients With Hematologic Malignancies

Phase 1
18 Years
Not Enrolling
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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Trial Information

A Phase I Study of Triapine and Cytarabine in Patients With Hematologic Malignancies


- 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

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.

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Mario Sznol, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vion Pharmaceuticals


United States: Federal Government

Study ID:




Start Date:

March 2003

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
  • blastic phase chronic myelogenous leukemia
  • refractory chronic lymphocytic leukemia
  • relapsing chronic myelogenous leukemia
  • chronic myelomonocytic leukemia
  • refractory anemia with excess blasts in transformation
  • refractory anemia with excess blasts
  • previously treated myelodysplastic syndromes
  • atypical chronic myeloid leukemia, BCR-ABL1 negative
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • Neoplasms
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009