Expired Study
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Buffalo, New York 14263


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00053144


Primary Contact:

Study Chair
Maria R. Baer, MD
Roswell Park Cancer Institute


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14263
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

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