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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00003735




Registration number
NCT00003735
Ethics application status
Date submitted
1/11/1999
Date registered
23/04/2004
Date last updated
24/07/2014

Titles & IDs
Public title
Chemotherapy in Treating Children With Relapsed Acute Leukemia, Acute Myeloid Leukemia, or Blastic Phase Chronic Myelogenous Leukemia
Scientific title
A Phase II Study of Oral Topotecan in Children With Relapsed Acute Leukemia
Secondary ID [1] 0 0
CCG-09714
Secondary ID [2] 0 0
09714
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - topotecan hydrochloride

Experimental: Stratum 1 - Stage 1 - 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.

Experimental: Stratum 2 - Stage 2 - 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.


Treatment: Drugs: topotecan hydrochloride
given by mouth

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
21 days

Eligibility
Key inclusion 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
Minimum age
No limit
Maximum age
21 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Colorado
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United States of America
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District of Columbia
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United States of America
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Illinois
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Indiana
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Iowa
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Michigan
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Minnesota
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Missouri
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Nebraska
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New Jersey
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United States of America
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New York
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North Carolina
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North Dakota
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Ohio
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Utah
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United States of America
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Washington
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United States of America
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Wisconsin
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Canada
State/province [23] 0 0
British Columbia
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Canada
State/province [24] 0 0
Nova Scotia

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00003735
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John S. Holcenberg, MD
Address 0 0
Seattle Children's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications