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

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
topotecan hydrochloride
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, blastic phase chronic myelogenous leukemia

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Long Beach Memorial Medical Center
  • Children's Hospital Los Angeles
  • Jonsson Comprehensive Cancer Center, UCLA
  • Children's Hospital of Orange County
  • UCSF Cancer Center and Cancer Research Institute
  • Children's Hospital of Denver
  • Children's National Medical Center
  • University of Chicago Cancer Research Center
  • Indiana University Cancer Center
  • University of Iowa Hospitals and Clinics
  • University of Michigan Comprehensive Cancer Center
  • CCOP - Kalamazoo
  • Mayo Clinic Cancer Center
  • Children's Mercy Hospital
  • University of Nebraska Medical Center
  • Cancer Institute of New Jersey
  • St. Joseph's Hospital and Medical Center
  • NYU School of Medicine's Kaplan Comprehensive Cancer Center
  • Memorial Sloan-Kettering Cancer Center
  • Herbert Irving Comprehensive Cancer Center
  • Lineberger Comprehensive Cancer Center, UNC
  • Veterans Affairs Medical Center - Fargo
  • CCOP - Merit Care Hospital
  • Children's Hospital Medical Center - Cincinnati
  • Ireland Cancer Center
  • Children's Hospital of Columbus
  • Doernbecher Children's Hospital
  • Children's Hospital of Philadelphia
  • Children's Hospital of Pittsburgh
  • Vanderbilt Cancer Center
  • University of Texas - MD Anderson Cancer Center
  • Huntsman Cancer Institute
  • Children's Hospital and Regional Medical Center - Seattle
  • Fred Hutchinson Cancer Research Center
  • University of Wisconsin Comprehensive Cancer Center
  • Princess Margaret Hospital for Children
  • British Columbia Children's Hospital
  • IWK Grace Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stratum 1 - Stage 1

Stratum 2 - Stage 2

Arm Description

Topotecan hydrochloride (0.8 mg/m²/day) by mouth for 21 days. Bone marrow will be obtained on approximately Day 28 of Course 1 and 2 and in any course where the CBC suggests that a relapse has occurred. One additional course may be given if the blood is cleared of blasts and the bone marrow is M1, M2 or M3. The patient is off protocol therapy if blasts are still present in the blood and the marrow is M3. Subsequent courses of topotecan may be given only if the bone marrow after Course 2 is M1 or M2. If the bone marrow is M2 on Day 28 of any course, another bone marrow aspirate will be done at the end of the next course. If the patient is in CR, a bone marrow aspirate will be required only every other course unless the peripheral blood suggests that a relapse has occurred. Each subsequent course should begin within six weeks of the start of the previous course.

Topotecan hydrochloride (0.8 mg/m²/day) by mouth for 21 days. Bone marrow will be obtained on approximately Day 28 of Course 1 and 2 and in any course where the CBC suggests that a relapse has occurred. One additional course may be given if the blood is cleared of blasts and the bone marrow is M1, M2 or M3. The patient is off protocol therapy if blasts are still present in the blood and the marrow is M3. Subsequent courses of topotecan may be given only if the bone marrow after Course 2 is M1 or M2. If the bone marrow is M2 on Day 28 of any course, another bone marrow aspirate will be done at the end of the next course. If the patient is in CR, a bone marrow aspirate will be required only every other course unless the peripheral blood suggests that a relapse has occurred. Each subsequent course should begin within six weeks of the start of the previous course.

Outcomes

Primary Outcome Measures

Disease Progression
For each stratum, this trial will determine topotecan to have insufficient activity for further investigation with probability 0.10 if the true response rate is 20%. For each stratum, this trial will determine topotecan to be of sufficient activity to warrant further investigation with probability 0.12 if the true response rate is 5%. Any patient who receives at least 21 days of therapy will be considered evaluable for response.

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 23, 2014
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003735
Brief Title
Chemotherapy in Treating Children With Relapsed Acute Leukemia, Acute Myeloid Leukemia, or Blastic Phase Chronic Myelogenous Leukemia
Official Title
A Phase II Study of Oral Topotecan in Children With Relapsed Acute Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 1998 (undefined)
Primary Completion Date
November 2002 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, blastic phase chronic myelogenous leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stratum 1 - Stage 1
Arm Type
Experimental
Arm Description
Topotecan hydrochloride (0.8 mg/m²/day) by mouth for 21 days. Bone marrow will be obtained on approximately Day 28 of Course 1 and 2 and in any course where the CBC suggests that a relapse has occurred. One additional course may be given if the blood is cleared of blasts and the bone marrow is M1, M2 or M3. The patient is off protocol therapy if blasts are still present in the blood and the marrow is M3. Subsequent courses of topotecan may be given only if the bone marrow after Course 2 is M1 or M2. If the bone marrow is M2 on Day 28 of any course, another bone marrow aspirate will be done at the end of the next course. If the patient is in CR, a bone marrow aspirate will be required only every other course unless the peripheral blood suggests that a relapse has occurred. Each subsequent course should begin within six weeks of the start of the previous course.
Arm Title
Stratum 2 - Stage 2
Arm Type
Experimental
Arm Description
Topotecan hydrochloride (0.8 mg/m²/day) by mouth for 21 days. Bone marrow will be obtained on approximately Day 28 of Course 1 and 2 and in any course where the CBC suggests that a relapse has occurred. One additional course may be given if the blood is cleared of blasts and the bone marrow is M1, M2 or M3. The patient is off protocol therapy if blasts are still present in the blood and the marrow is M3. Subsequent courses of topotecan may be given only if the bone marrow after Course 2 is M1 or M2. If the bone marrow is M2 on Day 28 of any course, another bone marrow aspirate will be done at the end of the next course. If the patient is in CR, a bone marrow aspirate will be required only every other course unless the peripheral blood suggests that a relapse has occurred. Each subsequent course should begin within six weeks of the start of the previous course.
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride
Other Intervention Name(s)
Hycamptamine, SK&B 104864-A, 9-dimethylaminomethyl-10-hydroxycamptothecin hydrochloride, IND #56, 270.
Intervention Description
given by mouth
Primary Outcome Measure Information:
Title
Disease Progression
Description
For each stratum, this trial will determine topotecan to have insufficient activity for further investigation with probability 0.10 if the true response rate is 20%. For each stratum, this trial will determine topotecan to be of sufficient activity to warrant further investigation with probability 0.12 if the true response rate is 5%. Any patient who receives at least 21 days of therapy will be considered evaluable for response.
Time Frame
21 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John S. Holcenberg, MD
Organizational Affiliation
Seattle Children's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-0700
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCSF Cancer Center and Cancer Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94115-0128
Country
United States
Facility Name
Children's Hospital of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010-2970
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5265
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0752
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-3330
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center, UNC
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Veterans Affairs Medical Center - Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102
Country
United States
Facility Name
CCOP - Merit Care Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Children's Hospital Medical Center - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Children's Hospital of Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205-2696
Country
United States
Facility Name
Doernbecher Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Children's Hospital and Regional Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Princess Margaret Hospital for Children
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
IWK Grace Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3J 3G9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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