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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Compare the event-free survival as a result of treatment with either CV or TPCV
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 - Defined as the time to death from any cause.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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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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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. Combining more than one drug may kill more tumor cells.

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy
regimens and comparing how well they work in treating children with low-grade astrocytomas or
other residual tumors of the brain.
Trial website
https://clinicaltrials.gov/show/NCT00002944
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

Summary results
Other publications