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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00053144
First received: January 27, 2003
Last updated: March 7, 2011
Last verified: March 2011

January 27, 2003
March 7, 2011
November 1999
February 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00053144 on ClinicalTrials.gov Archive Site
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Irinotecan and Cytarabine in Treating Patients With Refractory or Recurrent Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
Irinotecan And Cytarabine In Refractory or Relapsed Acute Myeloid Leukemia And In Chronic Myelogenous Leukemia In Myeloid Blast Transformation: Efficacy And In Vitro Correlates

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.

OBJECTIVES:

  • 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.

Interventional
Phase 1
Primary Purpose: Treatment
Leukemia
  • Drug: cytarabine
  • Drug: irinotecan hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 2003
February 2003   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 15 and over

Performance status

  • 0-3

Life expectancy

  • At least 4 weeks

Hematopoietic

  • See Disease Characteristics

Hepatic

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

Renal

  • Creatinine less than 1.5 times ULN

Other

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

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

Endocrine therapy

  • Not specified

Radiotherapy

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

Surgery

  • Not specified
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00053144
CDR0000269286, P30CA016056, RPCI-RPC-9901
Yes
Maria Baer, Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Study Chair: Maria R. Baer, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
March 2011

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