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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00107471




Registration number
NCT00107471
Ethics application status
Date submitted
5/04/2005
Date registered
6/04/2005
Date last updated
10/12/2013

Titles & IDs
Public title
Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma
Scientific title
A Phase I/II Study of Topotecan With G-CSF and Radiation Therapy in Children With Malignant Intrinsic Pontine Brainstem Gliomas of Childhood
Secondary ID [1] 0 0
CDR0000417842
Secondary ID [2] 0 0
ACNS0224
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Tumors 0 0
Central Nervous System Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Children's - Brain

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

Experimental: Dose Level I (0.5 mg/m^2) - Radiation Therapy + Topotecan hydrochloride daily before each dose of irradiation (radiation therapy) + filgrastim (G-CSF) (p.r.n)

Experimental: Dose Level 2 (0.6 mg/m^2) - Radiation Therapy + Topotecan hydrochloride daily before each dose of irradiation (radiation therapy) + filgrastim (G-CSF) (p.r.n.)


Treatment: Other: filgrastim
Given PO

Treatment: Drugs: topotecan hydrochloride
Given IV
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to treatment failure (e.g., tumor progression, tumor recurrence, or death from any cause)
Timepoint [1] 0 0
From date of enrollment until the first occurrence of relapse, progressive disease, secondary malignancy, or death or until last contact if none of these events occur, assessed up to 3 years
Secondary outcome [1] 0 0
Time to death
Timepoint [1] 0 0
From the time of study entry to the first occurrence of death by any cause

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Diagnosis of intrinsic pontine brain stem glioma within the past 30 days

* Histologic confirmation not required provided the tumor has a pontine epicenter AND exhibits diffuse (rather than focal) involvement of = 2/3 of the pons with or without extension to the adjacent medulla or midbrain* NOTE: *Brain stem tumors that do not meet these criteria must be histologically confirmed as grade III or IV malignant glioma
* Measurable disease by radiographic imaging

* Post-operative MRI required within the past 30 days if patient had a biopsy or surgical resection
* No disseminated disease
* No neurofibromatosis type 1

PATIENT CHARACTERISTICS:

Age

* 3 to 21 at diagnosis

Performance status

* Lansky 50-100% OR
* Karnofsky 50-100%

Life expectancy

* At least 8 weeks

Hematopoietic

* Absolute neutrophil count = 1,000/mm^3
* Platelet count = 100,000/mm^3 (transfusion independent)
* Hemoglobin = 10.0 g/dL (transfusion allowed)

Hepatic

* Bilirubin = 1.5 times upper limit of normal (ULN)
* ALT < 2.5 times ULN

Renal

* Creatinine clearance or radioisotope glomerular filtration rate = 70 mL/min OR
* Creatinine based on age as follows:

* No greater than 0.8 mg/dL (for patients = 5 years of age)
* No greater than 1.0 mg/dL (for patients 6 to 10 years of age)
* No greater than 1.2 mg/dL (for patients 11 to 15 years of age)
* No greater than 1.5 mg/dL (for patients over 15 years of age)

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Not severely somnolent or comatose

* Central cortical neurotoxicity scale < grade 3

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No concurrent immunomodulating agents

Chemotherapy

* No other concurrent anticancer chemotherapy

Endocrine therapy

* Concurrent corticosteroids allowed for neurological deficits related to the tumor

Radiotherapy

* No prior radiotherapy

Surgery

* See Disease Characteristics
* Prior biopsy or surgical resection for malignant brain stem glioma allowed

Other

* No other prior therapy for malignant brain stem glioma
Minimum age
3 Years
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
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 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
Royal Children's Hospital - Herston, Brisbane
Recruitment hospital [2] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [3] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
4029 - Herston, Brisbane
Recruitment postcode(s) [2] 0 0
5006 - North Adelaide
Recruitment postcode(s) [3] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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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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United States of America
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Connecticut
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Florida
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Hawaii
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United States of America
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Idaho
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United States of America
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Illinois
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Indiana
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Kansas
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Kentucky
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Maine
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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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Nevada
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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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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West Virginia
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United States of America
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Wisconsin
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Canada
State/province [35] 0 0
Ontario
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Canada
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Quebec
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Canada
State/province [37] 0 0
Saskatchewan
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Switzerland
State/province [38] 0 0
Bern

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Patricia L. Robertson, MD
Address 0 0
University of Michigan Rogel Cancer Center
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00107471