Completed

NCT Number: NCT00053144

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

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.

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Key information

Conditions

Leukemia Blast Crisis Bone Marrow Diseases Carcinogenesis Cell Transformation, Neoplastic Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia, Erythroblastic, Acute Leukemia, Megakaryoblastic, Acute Leukemia, Monocytic, Acute Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Acute Leukemia, Promyelocytic, Acute Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cytarabine

Drug

irinotecan hydrochloride

Drug

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start: 1999
Primary completion: 2003
Study completion: 2003
First posted: Jan 28, 2003
Registry last updated: Mar 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed