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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00028795




Registration number
NCT00028795
Ethics application status
Date submitted
4/01/2002
Date registered
27/01/2003
Date last updated
21/02/2014

Titles & IDs
Public title
Chemotherapy and Radiation Therapy After Surgery in Treating Children With Newly Diagnosed Astrocytoma, Glioblastoma Multiforme, Gliosarcoma, or Diffuse Intrinsic Pontine Glioma
Scientific title
A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma
Secondary ID [1] 0 0
COG-ACNS0126
Secondary ID [2] 0 0
ACNS0126
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Chemoradiotherapy -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Improved outcome
Timepoint [1] 0 0
Primary outcome [2] 0 0
Toxicity as assessed by NCI CTCAE v. 2.0
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Histologically confirmed newly diagnosed CNS tumor of the following types:

* High grade glioma (HGG) of one of the following histologies:

* Anaplastic astrocytoma (grade III)
* Glioblastoma multiforme (grade IV)
* Gliosarcoma
* Primary spinal cord malignant glioma
* Diffuse intrinsic pontine glioma (DIPG)

* Diagnosed by gadolinium-enhanced MRI
* At least 2/3 of tumor situated in the pons AND tumor clearly originated in the pons
* No diffuse leptomeningeal disease
* No tumors with features not typical of diffuse intrinsic brainstem glioma, including any of the following:

* Dorsally exophytic brainstem glioma
* Cervico-medullary junction tumor
* Focal low-grade glioma of the midbrain or brainstem
* No diffuse brainstem enlargement due to neurofibromatosis
* No primary brain stem malignant glioma
* No M+ disease (CSF positive for tumor or metastatic disease)
* Must begin study radiotherapy within 6 weeks after surgical resection (for HGG patients) or diagnosis (for DIPG patients)

PATIENT CHARACTERISTICS:

Age:

* 3 to 21

Performance status:

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

Life expectancy:

* At least 2 months

Hematopoietic:

* Absolute neutrophil count at least 1,000/mm^3
* Platelet count at least 100,000/mm^3*
* Hemoglobin at least 10.0 g/dL* NOTE: *Transfusion independent

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT less than 2.5 times ULN

Renal:

* Creatinine no greater than 1.5 times ULN

Other:

* No other concurrent malignancy
* Concurrent seizure disorder allowed if well controlled on anticonvulsants
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 months after completion of study treatment

PRIOR CONCURRENT THERAPY:

Biologic:

* No concurrent routine cytokine support

Chemotherapy:

* Not specified

Endocrine therapy:

* No concurrent corticosteroids except for increased intracranial pressure in patients with CNS tumors

Radiotherapy:

* See Disease Characteristics

Surgery:

* See Disease Characteristics

Other:

* No prior therapy for HGG or DIPG
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
NA
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
1/12/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2012
Sample size
Target
Accrual to date
Final
170
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [4] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [5] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [6] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 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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Colorado
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Connecticut
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Delaware
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District of Columbia
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Florida
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Georgia
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Hawaii
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Idaho
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maine
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Massachusetts
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Michigan
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Missouri
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Nebraska
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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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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Vermont
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Virginia
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Washington
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West Virginia
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Wisconsin
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Alberta
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British Columbia
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Manitoba
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Canada
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Newfoundland and Labrador
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Nova Scotia
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Ontario
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Saskatchewan
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Netherlands
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Groningen
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New Zealand
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Auckland
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San Juan
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Bern
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Geneva
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Lausanne

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
Kenneth J. Cohen, MD, MBA
Address 0 0
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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


Results not provided in https://clinicaltrials.gov/study/NCT00028795