Temozolomide Plus Lomustine Followed by Radiation Therapy in Treating Patients With High-Grade Malignant Glioma

• Status: Completed
• Trial end date: 2006-09-01
• 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. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of temozolomide plus lomustine followed by radiation therapy in treating patients who have high-grade malignant glioma.

• Phase: Phase 1
• 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 high-grade malignant glioma of one of the following subtypes:

• Glioblastoma

• Anaplastic astrocytoma

• Anaplastic oligoastrocytoma

• Gliomatosis cerebri

• No disseminated disease or primary spinal cord malignancies

• Measurable intracranial residual disease by MRI

PATIENT CHARACTERISTICS:

Age:

• 3 and over

• Under 22 at time of diagnosis

Performance status:

• Karnofsky 50-100% if over 10 years of age

• Lansky 50-100% if 10 years of age or under

Life expectancy:

• At least 8 weeks

Hematopoietic:

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

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

• Hemoglobin at least 8.0 g/dL (RBC transfusions allowed)

Hepatic:

• Bilirubin no greater than 1.5 times normal for age

• SGPT no greater than 2.5 times normal for age

• Albumin at least 2 g/dL

Renal:

• Creatinine no greater than 1.5 times normal for age OR

• Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal for age

Pulmonary:

• No dyspnea at rest

• No exercise intolerance

• Pulse oximetry at least 94%

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior biologic therapy

• No concurrent prophylactic hematopoietic growth factors

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Prior corticosteroid therapy allowed

• No concurrent corticosteroids as antiemetic

Radiotherapy:

• No prior radiotherapy

Surgery:

• No more than 31 days since prior maximal neurosurgical procedure

Other:

• No concurrent phenobarbital or cimetidine