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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/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
Other interventions - filgrastim
Treatment: Drugs - topotecan hydrochloride
Treatment: Other - radiation therapy

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.)


Other interventions: filgrastim
Given PO

Treatment: Drugs: topotecan hydrochloride
Given IV

Treatment: Other: radiation therapy
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Other
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/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
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
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Arizona
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Arkansas
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California
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Connecticut
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Florida
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Hawaii
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Idaho
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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
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Ontario
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Canada
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Quebec
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Canada
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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
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in
bone marrow or peripheral blood and may help the immune system recover from the side effects
of chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Topotecan may
make tumor cells more sensitive to radiation therapy . Giving topotecan and G-CSF together
with radiation therapy may be an effective treatment for brain stem glioma.

PURPOSE: This phase I/II trial is studying the side effects and best dose of topotecan when
given together with G-CSF and radiation therapy and to see how well they work in treating
young patients with newly diagnosed brain stem glioma.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00107471
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00107471