Chemotherapy and Radiation Therapy After Surgery in Treating Children With Newly Diagnosed Astrocytoma, Glioblastoma Multiforme, Gliosarcoma, or Diffuse Intrinsic Pontine Glioma

• Status: Completed
• Trial end date: 2012-03-01
• 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving chemotherapy together with radiation therapy after surgery followed by chemotherapy alone works in children with newly diagnosed astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Temozolomide

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed newly diagnosed CNS tumor of the following types:

• High grade glioma (HGG) of one of the following histologies:

• Anaplastic astrocytoma (grade III)

• Glioblastoma multiforme (grade IV)

• Gliosarcoma

• Primary spinal cord malignant glioma

• Diffuse intrinsic pontine glioma (DIPG)

• Diagnosed by gadolinium-enhanced MRI

• At least 2/3 of tumor situated in the pons AND tumor clearly originated in the pons

• No diffuse leptomeningeal disease

• No tumors with features not typical of diffuse intrinsic brainstem glioma, including any of the following:

• Dorsally exophytic brainstem glioma

• Cervico-medullary junction tumor

• Focal low-grade glioma of the midbrain or brainstem

• No diffuse brainstem enlargement due to neurofibromatosis

• No primary brain stem malignant glioma

• No M+ disease (CSF positive for tumor or metastatic disease)

• Must begin study radiotherapy within 6 weeks after surgical resection (for HGG patients) or diagnosis (for DIPG patients)

PATIENT CHARACTERISTICS:

Age:

• 3 to 21

Performance status:

• Karnofsky 50-100% OR

• Lansky 50-100%

Life expectancy:

• At least 2 months

Hematopoietic:

• Absolute neutrophil count at least 1,000/mm^3

• Platelet count at least 100,000/mm^3*

• Hemoglobin at least 10.0 g/dL* NOTE: *Transfusion independent

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• SGOT or SGPT less than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Other:

• No other concurrent malignancy

• Concurrent seizure disorder allowed if well controlled on anticonvulsants

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 2 months after completion of study treatment

PRIOR CONCURRENT THERAPY:

Biologic:

• No concurrent routine cytokine support

Chemotherapy:

• Not specified

Endocrine therapy:

• No concurrent corticosteroids except for increased intracranial pressure in patients with CNS tumors

Radiotherapy:

• See Disease Characteristics

Surgery:

• See Disease Characteristics

Other:

• No prior therapy for HGG or DIPG