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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
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Scientific title
A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma
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Secondary ID [1]
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COG-ACNS0126
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Secondary ID [2]
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ACNS0126
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Brain and Central Nervous System Tumors
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Condition category
Condition code
Cancer
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Brain
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Cancer
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Children's - Brain
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Cancer
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Neuroendocrine tumour (NET)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Chemoradiotherapy -
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Improved outcome
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Assessment method [1]
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Timepoint [1]
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Primary outcome [2]
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Toxicity as assessed by NCI CTCAE v. 2.0
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Assessment method [2]
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Timepoint [2]
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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
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Minimum age
3
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Maximum age
21
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2002
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Date of last participant enrolment
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Actual
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Date of last data collection
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Actual
1/03/2012
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Sample size
Target
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Accrual to date
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Final
170
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Recruitment in Australia
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NSW,QLD,SA,VIC,WA
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Sydney Children's Hospital - Randwick
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Children's Hospital at Westmead - Westmead
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Royal Children's Hospital - Brisbane
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Women's and Children's Hospital - North Adelaide
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Royal Children's Hospital - Parkville
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Princess Margaret Hospital for Children - Perth
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2031 - Randwick
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2145 - Westmead
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4029 - Brisbane
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5006 - North Adelaide
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3052 - Parkville
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6001 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving chemotherapy together with radiation therapy after surgery followed by chemotherapy alone works in children with newly diagnosed astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma.
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Trial website
https://clinicaltrials.gov/study/NCT00028795
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Trial related presentations / publications
Pollack IF, Hamilton RL, Burger PC, Brat DJ, Rosenblum MK, Murdoch GH, Nikiforova MN, Holmes EJ, Zhou T, Cohen KJ, Jakacki RI; Children's Oncology Group. Akt activation is a common event in pediatric malignant gliomas and a potential adverse prognostic marker: a report from the Children's Oncology Group. J Neurooncol. 2010 Sep;99(2):155-63. doi: 10.1007/s11060-010-0297-3. Epub 2010 Jul 4. Pollack IF, Hamilton RL, Sobol RW, Nikiforova MN, Nikiforov YE, Lyons-Weiler MA, LaFramboise WA, Burger PC, Brat DJ, Rosenblum MK, Gilles FH, Yates AJ, Zhou T, Cohen KJ, Finlay JL, Jakacki RI; Children's Oncology Group. Mismatch repair deficiency is an uncommon mechanism of alkylator resistance in pediatric malignant gliomas: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2010 Dec 1;55(6):1066-71. doi: 10.1002/pbc.22634. Cohen KJ, Heideman RL, Zhou T, Holmes EJ, Lavey RS, Bouffet E, Pollack IF. Temozolomide in the treatment of children with newly diagnosed diffuse intrinsic pontine gliomas: a report from the Children's Oncology Group. Neuro Oncol. 2011 Apr;13(4):410-6. doi: 10.1093/neuonc/noq205. Epub 2011 Feb 22. Cohen KJ, Pollack IF, Zhou T, Buxton A, Holmes EJ, Burger PC, Brat DJ, Rosenblum MK, Hamilton RL, Lavey RS, Heideman RL. Temozolomide in the treatment of high-grade gliomas in children: a report from the Children's Oncology Group. Neuro Oncol. 2011 Mar;13(3):317-23. doi: 10.1093/neuonc/noq191. Nicholson HS, Kretschmar CS, Krailo M, Bernstein M, Kadota R, Fort D, Friedman H, Harris MB, Tedeschi-Blok N, Mazewski C, Sato J, Reaman GH. Phase 2 study of temozolomide in children and adolescents with recurrent central nervous system tumors: a report from the Children's Oncology Group. Cancer. 2007 Oct 1;110(7):1542-50. doi: 10.1002/cncr.22961.
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Public notes
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Contacts
Principal investigator
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Kenneth J. Cohen, MD, MBA
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Address
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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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
Type
Citations or Other Details
Journal
Cohen KJ, Heideman RL, Zhou T, Holmes EJ, Lavey RS...
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Journal
Cohen KJ, Pollack IF, Zhou T, Buxton A, Holmes EJ,...
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Journal
Nicholson HS, Kretschmar CS, Krailo M, Bernstein M...
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Results not provided in
https://clinicaltrials.gov/study/NCT00028795
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