Acute Myeloid Leukemia Clinical Trial

Chemotherapy in Treating Children With Relapsed Acute Leukemia, Acute Myeloid Leukemia, or Blastic Phase Chronic Myelogenous Leukemia

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of topotecan in treating children who have relapsed acute leukemia, acute myeloid leukemia, or blast phase chronic myelogenous leukemia.

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Full Description

OBJECTIVES: I. Determine the response rate of patients with relapsed acute lymphocytic leukemia, acute myeloid leukemia, or blastic phase chronic myelogenous leukemia treated with oral topotecan. II. Determine the toxic effects and pharmacokinetics of this regimen in these patients.

OUTLINE: Patients are stratified by disease type (acute lymphocytic leukemia vs acute myeloid leukemia). Patients receive oral topotecan once daily on days 1-21. Courses repeat every 28 days in the absence of blasts in the blood, M3 bone marrow, or unacceptable toxicity. Patients are followed every 6 months until death.

PROJECTED ACCRUAL: A total of 50 patients (25 per stratum) will be accrued for this study within 2 years.

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Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically proven relapsed acute lymphocytic leukemia, acute myeloid leukemia, or blastic phase chronic myelogenous leukemia Refractory to conventional therapy and other therapies of higher priority May have concurrent extramedullary relapse except for testicular relapse or other extramedullary sites that may require concurrent radiotherapy

PATIENT CHARACTERISTICS: Age: 21 and under Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 times normal SGOT or SGPT less than 5 times normal Renal: Creatinine no greater than 1.5 times normal Other: Able to take oral liquid medication No GI neuropathy No other condition that may affect absorption of drug No diabetes mellitus Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior bone marrow transplantation (BMT) or peripheral blood stem cell transplantation (PBSCT) allowed and recovered At least 2 weeks since prior cytokine therapy and recovered No concurrent immune modulator therapy No concurrent cytokines including interleukin-11, interleukin-2, and epoetin alfa Chemotherapy: At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered No more than 3 prior chemotherapy regimens No other concurrent chemotherapy Endocrine therapy: No concurrent steroids Radiotherapy: No prior craniospinal radiotherapy Prior total body irradiation allowed as part of BMT or PBSCT and recovered Concurrent radiotherapy for localized painful lesions allowed Surgery: Not specified Other: No concurrent metoclopramide or cisapride to maintain motility or gastric emptying No concurrent H2 antagonists No concurrent proton pump inhibitors No concurrent antacids for gastritis, gastroesophageal reflux, or ulcers (gastric or duodenal) No antacid therapy for 6 hours before and for 90 minutes after topotecan administration

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

11

Study ID:

NCT00003735

Recruitment Status:

Completed

Sponsor:

Children's Oncology Group

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There are 38 Locations for this study

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Long Beach Memorial Medical Center
Long Beach California, 90806, United States
Children's Hospital Los Angeles
Los Angeles California, 90027, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles California, 90095, United States
Children's Hospital of Orange County
Orange California, 92868, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco California, 94115, United States
Children's Hospital of Denver
Denver Colorado, 80218, United States
Children's National Medical Center
Washington District of Columbia, 20010, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
CCOP - Kalamazoo
Kalamazoo Michigan, 49007, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
Children's Mercy Hospital
Kansas City Missouri, 64108, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
St. Joseph's Hospital and Medical Center
Paterson New Jersey, 07503, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York New York, 10016, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill North Carolina, 27599, United States
Veterans Affairs Medical Center - Fargo
Fargo North Dakota, 58102, United States
CCOP - Merit Care Hospital
Fargo North Dakota, 58122, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati Ohio, 45229, United States
Ireland Cancer Center
Cleveland Ohio, 44106, United States
Children's Hospital of Columbus
Columbus Ohio, 43205, United States
Doernbecher Children's Hospital
Portland Oregon, 97201, United States
Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh
Pittsburgh Pennsylvania, 15213, United States
Vanderbilt Cancer Center
Nashville Tennessee, 37232, United States
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84132, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle Washington, 98105, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Princess Margaret Hospital for Children
Perth Western Australia, 6001, Australia
British Columbia Children's Hospital
Vancouver British Columbia, V6H 3, Canada
IWK Grace Health Centre
Halifax Nova Scotia, B3J 3, Canada

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

11

Study ID:

NCT00003735

Recruitment Status:

Completed

Sponsor:


Children's Oncology Group

How clear is this clinincal trial information?

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