Irinotecan and Cytarabine in Treating Patients With Refractory or Recurrent Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
NCT ID: NCT00053144
Last Updated: 2011-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
1999-11-30
2003-03-31
Brief Summary
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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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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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cytarabine
irinotecan hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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
15 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Roswell Park Cancer Institute
OTHER
Responsible Party
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Roswell Park Cancer Institute
Principal Investigators
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Maria R. Baer, MD
Role: STUDY_CHAIR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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RPCI-RPC-9901
Identifier Type: -
Identifier Source: secondary_id
CDR0000269286
Identifier Type: -
Identifier Source: org_study_id
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