NCT00002944
Combination Chemotherapy in Treating Children With Progressive Brain Tumors
PHASE3
COMPLETED
NCT00002944
INTERVENTIONAL
Chemotherapy for Progressive Low Grade Astrocytoma in Children Less Than Ten Years Old
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.
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
Brain Tumors
Central Nervous System Tumors
- TREATMENT
-
- Type: DRUG
- Name: carboplatin
- Description: Given IV
- Arm Group Labels: Regimen A (CV Chemotherapy)
-
- Type: DRUG
- Name: lomustine
- Description: Given IV
- Arm Group Labels: Regimen B (TPCV Chemotherapy)
-
- Type: DRUG
- Name: procarbazine hydrochloride
- Description: Given PO
- Arm Group Labels: Regimen B (TPCV Chemotherapy)
-
- Type: DRUG
- Name: thioguanine
- Description: Given PO
- Arm Group Labels: Regimen B (TPCV Chemotherapy)
-
- Type: DRUG
- Name: vincristine sulfate
- Description: Given PO and IV
- Arm Group Labels: Regimen A (CV Chemotherapy), Regimen B (TPCV Chemotherapy)
- Children's Oncology Group