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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00006024
Registration number
NCT00006024
Ethics application status
Date submitted
5/07/2000
Date registered
27/01/2003
Date last updated
13/02/2014
Titles & IDs
Public title
Temozolomide Plus Lomustine Followed by Radiation Therapy in Treating Patients With High-Grade Malignant Glioma
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Scientific title
A Phase I Study of Temozolomide and CCNU in Pediatric Patients With Newly Diagnosed Incompletely Resected Non-Brainstem High-Grade Gliomas
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Secondary ID [1]
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COG-ADVL0011
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Secondary ID [2]
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ADVL0011
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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 Tumor
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Central Nervous System Tumor
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Condition category
Condition code
Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Brain
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Cancer
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Children's - Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Pre and Post radiation Chemotherapy -
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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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Progression Free Survival
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Assessment method [1]
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This trial is a phase I evaluation of temozolomide in combination with a fixed dose of CCNU with the starting dose for temozolomide
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Timepoint [1]
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Length of study
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
* Histologically confirmed high-grade malignant glioma of one of the following subtypes:
* Glioblastoma
* Anaplastic astrocytoma
* Anaplastic oligoastrocytoma
* Gliomatosis cerebri
* No disseminated disease or primary spinal cord malignancies
* Measurable intracranial residual disease by MRI
PATIENT CHARACTERISTICS:
Age:
* 3 and over
* Under 22 at time of diagnosis
Performance status:
* Karnofsky 50-100% if over 10 years of age
* Lansky 50-100% if 10 years of age or under
Life expectancy:
* At least 8 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,000/mm^3
* Platelet count at least 100,000/mm^3 (transfusion independent)
* Hemoglobin at least 8.0 g/dL (RBC transfusions allowed)
Hepatic:
* Bilirubin no greater than 1.5 times normal for age
* SGPT no greater than 2.5 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
Pulmonary:
* No dyspnea at rest
* No exercise intolerance
* Pulse oximetry at least 94%
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior biologic therapy
* No concurrent prophylactic hematopoietic growth factors
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Prior corticosteroid therapy allowed
* No concurrent corticosteroids as antiemetic
Radiotherapy:
* No prior radiotherapy
Surgery:
* No more than 31 days since prior maximal neurosurgical procedure
Other:
* No concurrent phenobarbital or cimetidine
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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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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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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
1/11/2000
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2006
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Sample size
Target
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Accrual to date
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Final
32
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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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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Recruitment postcode(s) [6]
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6001 - Perth
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Recruitment outside Australia
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Alabama
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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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Other collaborator category [1]
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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
Ethics application status
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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. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of temozolomide plus lomustine followed by radiation therapy in treating patients who have high-grade malignant glioma.
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Trial website
https://clinicaltrials.gov/study/NCT00006024
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Trial related presentations / publications
Jakacki RI, Yates A, Blaney SM, Zhou T, Timmerman R, Ingle AM, Flom L, Prados MD, Adamson PC, Pollack IF. A phase I trial of temozolomide and lomustine in newly diagnosed high-grade gliomas of childhood. Neuro Oncol. 2008 Aug;10(4):569-76. doi: 10.1215/15228517-2008-019. Epub 2008 May 22.
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Public notes
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Contacts
Principal investigator
Name
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Regina Jakacki, MD
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Address
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University of Pittsburgh
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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
Jakacki RI, Yates A, Blaney SM, Zhou T, Timmerman ...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT00006024
Download to PDF