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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00008424




Registration number
NCT00008424
Ethics application status
Date submitted
6/01/2001
Date registered
5/06/2003
Date last updated
5/05/2014

Titles & IDs
Public title
Irinotecan in Treating Children With Refractory or Advanced Solid Tumors Who Are Receiving Anticonvulsants
Scientific title
A Phase I Study of Irinotecan in Patients With Refractory Solid Tumors Who Are Concomitantly Receiving Anticonvulsants
Secondary ID [1] 0 0
COG-P9871
Secondary ID [2] 0 0
P9871
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unspecified Childhood Solid Tumor, Protocol Specific 0 0
Condition category
Condition code

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

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

Outcomes
Primary outcome [1] 0 0
Maximum tolerable dose (MTD) of irinotecan
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed malignancy refractory to conventional therapy or for which no
conventional therapy exists

- Histologic confirmation not required for brain stem tumors

- Concurrently on anticonvulsants at a steady level for at least 2 weeks

PATIENT CHARACTERISTICS:

Age:

- 1-21 years old

Performance status:

- Karnofsky 50-100% (over 10 years of age)

- Lansky 50-100% (10 years of age or under)

Life expectancy:

- At least 8 weeks

Hematopoietic:

- Neutrophil count at least 1,000/mm3

- Platelet count at least 100,000/mm3 (transfusion independent)

- Hemoglobin at least 8.0 g/dL (red blood cell transfusions allowed)

Hepatic:

- Bilirubin no greater than 1.5 times normal for age

- SGPT less than 5 times normal for age

- Albumin at least 2 g/dL

Renal:

- Creatinine no greater than 1.5 times normal for age OR

- Creatinine clearance or radioisotope glomerular filtration rate at least lower limit
of normal for age

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No uncontrolled infection

- No evidence of active graft-vs-host disease

- Neurologic deficits for CNS tumors stable for at least 2 weeks prior to study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 1 week since prior antineoplastic biologic therapy

- At least 6 months since prior allogeneic stem cell transplantation

- At least 1 week since prior growth factors

- No concurrent sargramostim (GM-CSF)

- No concurrent prophylactic growth factors during first course of study therapy

- Recovered from prior immunotherapy

Chemotherapy:

- At least 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea)
and recovered

Endocrine therapy:

- Concurrent dexamethasone for CNS tumors with increased intracranial pressure allowed
if dose stable or decreasing for at least 2 weeks prior to study

Radiotherapy:

- At least 2 weeks since prior local palliative radiotherapy (small part)

- At least 6 months since prior craniospinal radiotherapy

- At least 6 months since prior radiotherapy to at least 50% of pelvis

- At least 6 weeks since prior substantial bone marrow radiotherapy

- Recovered from prior radiotherapy

Surgery:

- Not specified

Other:

- No other concurrent investigational agent
Minimum age
1 Year
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
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
1/10/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [2] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [3] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
5006 - North Adelaide
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment postcode(s) [3] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arkansas
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United States of America
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California
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Colorado
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Washington
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United States of America
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Wisconsin
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Canada
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Ontario
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Canada
State/province [27] 0 0
Quebec

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 tumor cells from dividing so
they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of irinotecan in treating children with
refractory or advanced solid tumors who are receiving anticonvulsants.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00008424
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Albert Moghrabi, MD
Address 0 0
Hopital Sainte Justine
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00008424