Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00002944




Registration number
NCT00002944
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
9/09/2013

Titles & IDs
Public title
Combination Chemotherapy in Treating Children With Progressive Brain Tumors
Scientific title
Chemotherapy for Progressive Low Grade Astrocytoma in Children Less Than Ten Years Old
Secondary ID [1] 0 0
CCG-A9952
Secondary ID [2] 0 0
A9952
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Tumors 0 0
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
Treatment: Drugs - carboplatin
Treatment: Drugs - lomustine
Treatment: Drugs - procarbazine hydrochloride
Treatment: Drugs - thioguanine
Treatment: Drugs - vincristine sulfate

Experimental: Regimen A (CV Chemotherapy) - Induction will consist of 10 weeks of therapy (carboplatin, vincristine sulfate),followed by 2 weeks without chemotherapy. Induction should only be interrupted in the event of grade 3 neurotoxicity, grade 2 renal toxicity, grade 4 hematologic toxicity, or tumor progression. Maintenance-Four Courses (2 cycles/course) commences on Day 84 (week 12) of Induction or when peripheral counts recover with ANC \>1,000/$L and platelet count \>100,000/$L. Each cycle will consist of 4 weekly doses of carboplatin, three weekly doses of vincristine sulfate (given concomitantly with the first 3 weeks of carboplatin), followed by two weeks of rest for a total of 6 weeks. Maintenance will continue for a total of 8 cycles.

Experimental: Regimen B (TPCV Chemotherapy) - Each cycle of chemotherapy consists of 4 days of oral chemotherapy (Thioguanine, procarbazine hydrochloride, Lomustine and Vincristine sulfate beginning Day 0, followed by vincristine sulfate IV on Days 14 and 28. The cycle is repeated every 6 weeks (42 days). A total of 8 cycles will be given.


Treatment: Drugs: carboplatin
Given IV

Treatment: Drugs: lomustine
Given IV

Treatment: Drugs: procarbazine hydrochloride
Given PO

Treatment: Drugs: thioguanine
Given PO

Treatment: Drugs: vincristine sulfate
Given PO and IV
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event Free Survival
Timepoint [1] 0 0
Time from study entry until disease progression, death without progression of disease, occurrence of a second malignant neoplasm or last follow-up, whichever comes first, assessed up to 5 years
Secondary outcome [1] 0 0
Survival
Timepoint [1] 0 0
5 years

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Pathologically confirmed low grade residual astrocytomas or other eligible residual tumors of the brain interpreted as low grade (WHO grades I and II) such as the following:

* Glial Tumors

* Astrocytic tumors

* Low grade astrocytoma (variants: fibrillary, protoplasmic, gemistocytic)
* Pilocytic astrocytoma
* Pleomorphic xanthoastrocytomas
* Subependymal giant cell astrocytoma
* Infantile desmoplastic astrocytoma
* Low grade oligodendroglial tumors

* Low grade oligodendroglioma
* Low grade mixed gliomas

* Oligo-astrocytoma
* Neuronal Tumors

* Ganglioglioma (excluding tumors with anaplastic astrocytic components)
* Infantile desmoplastic ganglioglioma
* Chiasmatic-hypothalamic tumor without histologic confirmation
* All of the following diagnostic tests (radiological or clinical evidence of progression, surgery, or confirmatory MRI) must be carried out within 6 weeks of enrollment into this study
* Progressive disease following surgical excision based on clear radiological or clinical evidence of progression, or an incomplete excision (less than 95% or greater than 1.5 cm2) with necessity to begin treatment because of a risk of neurologic impairment with progression
* Chiasmatic lesions that have contiguous extensions of tumor into other regions of the visual pathways demonstrated on contrast MRI will be eligible for study without histopathological confirmation
* Patients with neurofibromatosis who have radiographic diagnosis of chiasmatic-hypothalamic tumor are eligible for the study, without requiring a biopsy confirmation of tumor histology, but not unless tumor progression is documented radiographically
* No intrinsic brain stem tumors of the pons or isolated optic nerve tumors without definitive involvement of the optic chiasm

PATIENT CHARACTERISTICS:

Age:

* Under 10

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count greater than 1,000/mm^3 (arm II)
* Platelet count greater than 100,000/mm^3 (arm II)

Hepatic:

* Not specified

Renal:

* Creatinine less than 1.5 times upper limit of normal for age OR
* Creatinine clearance or radioisotope GFR greater than 70 mL/min or equivalent GFR as determined by the institutional normal range

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy for the tumor

Endocrine therapy:

* Prior corticosteroid therapy allowed

Radiotherapy:

* No prior radiotherapy for the tumor

Surgery:

* See Disease characteristics

Other:

* Prior diuretic therapy allowed
Minimum age
No limit
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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 3
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
1/04/1997
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2012
Sample size
Target
Accrual to date
Final
428
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [2] 0 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [3] 0 0
Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [5] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2310 - Newcastle
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4029 - Brisbane
Recruitment postcode(s) [5] 0 0
6001 - Perth
Recruitment outside Australia
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Alabama
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Arizona
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Arkansas
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Connecticut
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Delaware
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Mississippi
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New Mexico
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New York
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North Carolina
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Tennessee
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Utah
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Vermont
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West Virginia
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Newfoundland and Labrador
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Saskatchewan
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Netherlands
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Groningen
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Auckland
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Switzerland
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Bern
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Switzerland
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Geneva

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
Joann Ater, MD
Address 0 0
M.D. Anderson Cancer Center
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

TypeCitations or Other Details
Journal Ater JL, Zhou T, Holmes E, Mazewski CM, Booth TN, ... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00002944