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Home > "C" Clinical Trials Conditions > Chemotherapy in Treating Children With Relapsed Acute Leukemia, Acute Myeloid Leukemia, or Blastic Phase Chronic Myelogenous Leukemia

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



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

For Condition: recurrent childhood acute myeloid leukemia,blastic phase chronic myelogenous leukemia,recurrent childhood acute lymphoblastic leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Children's Cancer Group
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JohnHolcenberg,  Study Chair,  Children's Cancer Group

University of Texas - MD Anderson Cancer Center
Houston,  Texas,  77030-4009
United States
 

UCSF Cancer Center and Cancer Research Institute
San Francisco,  California,  94115-0128
United States
 

Veterans Affairs Medical Center - Fargo
Fargo,  North Dakota,  58102
United States
 

Children's National Medical Center
Washington D.C.,  District of Columbia,  20010-2970
United States
 

Huntsman Cancer Institute
Salt Lake City,  Utah,  84132
United States
 

Lineberger Comprehensive Cancer Center, UNC
Chapel Hill,  North Carolina,  27599-7295
United States
 

Cancer Institute of New Jersey
New Brunswick,  New Jersey,  08901
United States
 

Children's Hospital of Columbus
Columbus,  Ohio,  43205-2696
United States
 

Children's Hospital of Orange County
Orange,  California,  92868
United States
 

University of Wisconsin Comprehensive Cancer Center
Madison,  Wisconsin,  53792
United States
 

British Columbia Children's Hospital
Vancouver,  British Columbia,  V6H 3V4
Canada
 

Indiana University Cancer Center
Indianapolis,  Indiana,  46202-5265
United States
 

CCOP - Kalamazoo
Kalamazoo,  Michigan,  49007-3731
United States
 

Herbert Irving Comprehensive Cancer Center
New York City,  New York,  10032
United States
 

University of Iowa Hospitals and Clinics
Iowa City,  Iowa,  52242
United States
 

Fred Hutchinson Cancer Research Center
Seattle,  Washington,  98109
United States
 

Ireland Cancer Center
Cleveland,  Ohio,  44106-5065
United States
 

Children's Hospital Los Angeles
Los Angeles,  California,  90027-0700
United States
 

Doernbecher Children's Hospital
Portland,  Oregon,  97201-3098
United States
 

Princess Margaret Hospital for Children
Perth,  Western Australia,  6001
Australia
 

Mayo Clinic Cancer Center
Rochester,  Minnesota,  55905
United States
 

University of Nebraska Medical Center
Omaha,  Nebraska,  68198-3330
United States
 

Memorial Sloan-Kettering Cancer Center
New York City,  New York,  10021
United States
 

Children's Hospital of Denver
Denver,  Colorado,  80218
United States
 

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles,  California,  90095-1781
United States
 

University of Michigan Comprehensive Cancer Center
Ann Arbor,  Michigan,  48109-0752
United States
 

IWK Grace Health Centre
Halifax,  Nova Scotia,  B3J 3G9
Canada
 

NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City,  New York,  10016
United States
 

CCOP - Merit Care Hospital
Fargo,  North Dakota,  58122
United States
 

Children's Mercy Hospital
Kansas City,  Missouri,  64108
United States
 

Vanderbilt Cancer Center
Nashville,  Tennessee,  37232-6838
United States
 

Children's Hospital and Regional Medical Center - Seattle
Seattle,  Washington,  98105
United States
 

Children's Hospital of Pittsburgh
Pittsburgh,  Pennsylvania,  15213
United States
 

Children's Hospital of Philadelphia
Philadelphia,  Pennsylvania,  19104
United States
 

Children's Hospital Medical Center - Cincinnati
Cincinnati,  Ohio,  45229-3039
United States
 

Long Beach Memorial Medical Center
Long Beach,  California,  90806
United States
 

University of Chicago Cancer Research Center
Chicago,  Illinois,  60637
United States
 

St. Joseph's Hospital and Medical Center
Paterson,  New Jersey,  07503
United States
 


Additional Information:
Study ID Numbers:
  CDR0000066850;  CCG-09714
Study Start Date: December 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003735

Other Recurrent Childhood Acute Lymphoblastic Leukemia Studies:
1. Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia

2. Amifostine and High-Dose Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Chronic Myelogenous Leukemia

3. Chemotherapy in Treating Patients With Newly Diagnosed Acute or Chronic Myelogenous Leukemia or Myelodysplastic Syndrome

4. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia

5. 3-AP and High-Dose Cytarabine in Treating Patients With Advanced Hematologic Malignancies

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