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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 27, 2003

Last Updated Date

March 7, 2011

Start Date ^ICMJE

November 1999

Primary Completion Date

February 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00053144 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Irinotecan And Cytarabine In Refractory or Relapsed Acute Myeloid Leukemia And In Chronic Myelogenous Leukemia In Myeloid Blast Transformation: Efficacy And In Vitro Correlates

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.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Primary Purpose: Treatment

Condition ^ICMJE

Leukemia

Intervention ^ICMJE

Drug: cytarabine
Drug: irinotecan hydrochloride

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

March 2003

Primary Completion Date

February 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

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

Gender

Both

Ages

15 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00053144

Other Study ID Numbers ^ICMJE

CDR0000269286, P30CA016056, RPCI-RPC-9901

Has Data Monitoring Committee

Yes

Responsible Party

Maria Baer, Roswell Park Cancer Institute

Study Sponsor ^ICMJE

Roswell Park Cancer Institute

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Maria R. Baer, MD

Roswell Park Cancer Institute

Information Provided By

Roswell Park Cancer Institute

Verification Date

March 2011

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

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