Radiation Therapy, Temozolomide, and Lomustine in Treating Young Patients With Newly Diagnosed Gliomas

• Status: Completed
• Trial end date: 2017-06-30
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide and lomustine after surgery may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying how well giving radiation therapy together with temozolomide and lomustine works in treating young patients with newly diagnosed gliomas.

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

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed, newly diagnosed high-grade glioma of 1 of the following histologies:

• Anaplastic astrocytoma

• Glioblastoma multiforme

• Gliosarcoma

• Primary spinal cord malignant gliomas allowed

• No primary brainstem tumors

• Has undergone surgical resection or biopsy of the tumor within the past 31 days

• Pre-operative and post-operative brain MRI with and without gadolinium-contrast OR pre-operative and post-operative spine MRI for spinal cord primaries

• Post-operative MRI not required for patients who undergo biopsy only

• No evidence of neuraxis dissemination

• Spine MRI and cerebrospinal fluid cytology required only if clinically indicated

PATIENT CHARACTERISTICS:

Age

• 3 to 21

Performance status

• Karnofsky 50-100% (for patients > 16 years of age)

• Lansky 50-100% (for patients ≤ 16 years of age)

Life expectancy

• At least 8 weeks

Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm^3

• Platelet count ≥ 100,000/mm^3 (transfusion independent)

• Hemoglobin ≥ 8 g/dL (transfusions allowed)

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

• ALT ≤ 2.5 times ULN

• Albumin ≥ 2 g/dL

Renal

• Creatinine ≤ 1.5 times ULN OR

• Creatinine clearance or radioisotope glomerular filtration rate ≥ lower limit of normal

Pulmonary

• No evidence of dyspnea at rest

• No exercise intolerance

• Pulse oximetry ≥ 94% (if determination is clinically indicated)

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 2 months after study participation

• Able to swallow oral medication

• Seizures allowed provided they are well controlled with anticonvulsants

• No hypersensitivity to temozolomide

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic agents

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Prior corticosteroids allowed

• No concurrent corticosteroids as an antiemetic

• Concurrent corticosteroids allowed only for treatment of increased intracranial pressure

Radiotherapy

• No concurrent radiotherapy using cobalt-60

Surgery

• See Disease Characteristics

Other

• No other prior treatment

• No concurrent phenobarbital or cimetidine

• No concurrent co-trimoxazole for Pneumocystis carinii pneumonia prophylaxis during study chemoradiotherapy