Expired Study
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Tampa, Florida 33612


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/II trial to study the effectiveness of combination chemotherapy in treating patients who have previously untreated acute myeloid leukemia.

Study summary:

OBJECTIVES: - Determine the maximum tolerated dose (MTD) of topotecan when combined with daunorubicin, cytarabine, and etoposide in patients with de novo acute myeloid leukemia. - Determine the efficacy of this regimen at the MTD of topotecan by measuring the complete response rate in this patient population. - Determine the days of hospitalization and number of infections associated with this regimen in these patients. - Correlate serum levels of topotecan and etoposide with the expression of topoisomerase I and II in tumor cells and in peripheral blood mononuclear cells (PBMN), as well as with toxicity and response rate in these patients. - Correlate tumor cell and PBMN expression and activity of topoisomerase I and II with hematological toxicity and clinical response in these patients. - Correlate levels of activation of STAT signaling proteins with expression of bcl-2 family proteins and response to chemotherapy in these patients. OUTLINE: This is a dose-escalation study of topotecan (phase I) followed by a response rate-determination (phase II) study. Patients receive induction chemotherapy with daunorubicin IV over 10-15 minutes on days 1-3, cytarabine IV continuously on days 1-5, topotecan IV continuously on days 6-8, and etoposide IV over 60 minutes on days 9 and 10. Within 4 weeks of hematologic recovery, patients achieving remission after induction receive consolidation chemotherapy with cytarabine IV over 1 hour every 12 hours on days 1, 3, and 5. Subsequent courses of consolidation chemotherapy begin within 2 weeks of documentation of hematologic recovery from the prior consolidation course. Consolidation chemotherapy continues for 4 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive induction chemotherapy at the recommended phase II dose. Patients are followed at 1 month, every 2 months for 1 year, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 3-36 patients (phase I) and then an additional 24-27 patients (phase II) will be accrued for this study within 4 years.


DISEASE CHARACTERISTICS: - Histologically confirmed newly diagnosed, previously untreated acute myeloid leukemia (AML) - All FAB types, M0-M7, excluding M3 - No AML after myelodysplastic syndrome PATIENT CHARACTERISTICS: Age: - 16 to 59 Performance status: - Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin less than 2 mg/dL - SGOT/SGPT normal unless due to leukemic disease - Alkaline phosphatase normal unless due to leukemic disease Renal: - Creatinine no greater than 2.0 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular: - Ejection fraction at least 50% by MUGA - No myocardial infarction or serious ventricular arrhythmia within the past 6 months Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other prior malignancy within the past 5 years except resected skin cancer - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior topotecan or any other DNA topoisomerase I inhibitor (e.g., irinotecan, aminocamptothecin, or nitrocamptothecin) or etoposide for any prior malignancy Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified



Primary Contact:

Study Chair
Hussain I. Saba, MD, PhD
H. Lee Moffitt Cancer Center and Research Institute

Backup Contact:


Location Contact:

Tampa, Florida 33612
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 18, 2018

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