Irinotecan and Cytarabine in Treating Patients With Refractory or Recurrent Acute Myeloid Leukemia or Chronic Myelogenous Leukemia

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. Identifier: NCT00053144
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : March 8, 2011
National Cancer Institute (NCI)
Information provided by:
Roswell Park Cancer Institute

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of combining irinotecan with cytarabine in treating patients who have refractory or recurrent acute myeloid leukemia or chronic myelogenous leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Drug: cytarabine Drug: irinotecan hydrochloride Phase 1

Detailed Description:


  • Determine the activity of irinotecan and cytarabine in patients with refractory or recurrent acute myeloid leukemia or chronic myelogenous leukemia in myeloid blast transformation.
  • Determine the pharmacokinetics of this regimen in these patients.
  • Determine the maximum tolerated dose of irinotecan in this regimen in these patients.
  • Correlate the clinical activity of this drug with cellular endpoints associated with DNA synthesis inhibition, DNA repair, induction of apoptosis, and drug resistance in these patients.

OUTLINE: This is a dose-escalation study of irinotecan.

Patients receive irinotecan IV over 90 minutes and cytarabine IV over 60 minutes on days 1-6. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. An additional 9 patients with refractory/relapsed acute myeloid leukemia and 9 patients with chronic myelogenous leukemia in myeloid blast transformation are treated at the MTD.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 2.5 years.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Irinotecan And Cytarabine In Refractory or Relapsed Acute Myeloid Leukemia And In Chronic Myelogenous Leukemia In Myeloid Blast Transformation: Efficacy And In Vitro Correlates
Study Start Date : November 1999
Actual Primary Completion Date : February 2003
Actual Study Completion Date : March 2003

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed acute myeloid leukemia (M0-M7)

    • De novo or secondary disease

      • Previously treated and refractory to prior therapy (which has included high-dose cytarabine and an anthracycline)
    • Antecedent hematologic disorders allowed OR
  • Histologically confirmed Philadelphia chromosome-positive chronic myelogenous leukemia in myeloid blast transformation

    • Treated or untreated
    • Blast transformation defined by at least 20% blasts in marrow and/or blood
    • Myeloid lineage defined by immunophenotyping



  • 15 and over

Performance status

  • 0-3

Life expectancy

  • At least 4 weeks


  • See Disease Characteristics


  • Bilirubin less than 2 times upper limit of normal (ULN)
  • SGOT less than 2 times ULN


  • Creatinine less than 1.5 times ULN


  • Not pregnant or nursing
  • Negative pregnancy test
  • No other concurrent serious medical or psychiatric illness that would preclude study consent


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • Prior chemotherapy for an antecedent malignancy or other medical condition allowed

Endocrine therapy

  • Not specified


  • Prior radiotherapy for an antecedent malignancy or other medical condition allowed


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00053144

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Study Chair: Maria R. Baer, MD Roswell Park Cancer Institute

Responsible Party: Maria Baer, Roswell Park Cancer Institute Identifier: NCT00053144     History of Changes
Other Study ID Numbers: CDR0000269286
P30CA016056 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2003    Key Record Dates
Last Update Posted: March 8, 2011
Last Verified: March 2011

Keywords provided by Roswell Park Cancer Institute:
recurrent adult acute myeloid leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
secondary acute myeloid leukemia
blastic phase chronic myelogenous leukemia
relapsing chronic myelogenous leukemia
adult acute monocytic leukemia (M5b)
adult acute erythroid leukemia (M6)
adult acute megakaryoblastic leukemia (M7)
adult acute minimally differentiated myeloid leukemia (M0)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute promyelocytic leukemia (M3)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs