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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
Scientific title
A Phase I Study of Temozolomide and CCNU in Pediatric Patients With Newly Diagnosed Incompletely Resected Non-Brainstem High-Grade Gliomas
Secondary ID [1] 0 0
COG-ADVL0011
Secondary ID [2] 0 0
ADVL0011
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Pre and Post radiation Chemotherapy -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
Length of study

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
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
Not applicable
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2000
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
32
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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Arizona
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Arkansas
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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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Idaho
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Illinois
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Iowa
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Kentucky
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Louisiana
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Maine
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Massachusetts
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Tennessee
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Vermont
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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
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.
Trial website
https://clinicaltrials.gov/study/NCT00006024
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.
Public notes

Contacts
Principal investigator
Name 0 0
Regina Jakacki, MD
Address 0 0
University of Pittsburgh
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/study/NCT00006024