Combination Chemotherapy in Treating Children With Progressive Brain Tumors

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Lomustine; Procarbazine; Thioguanine; Vincristine

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