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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/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
Treatment: Drugs - lomustine
Treatment: Drugs - temozolomide

Experimental: Pre and Post radiation Chemotherapy -


Treatment: Drugs: lomustine


Treatment: Drugs: temozolomide
Intervention code [1] 0 0
Treatment: Drugs
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
N/A
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
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Alabama
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Arizona
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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/ct2/show/NCT00006024
Trial related presentations / publications
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/ct2/show/NCT00006024