Capecitabine and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Nonmetastatic Brain Stem Glioma or High-Grade Glioma

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine may make tumor cells more sensitive to radiation therapy. Giving capecitabine together with radiation therapy may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when given together with radiation therapy in treating young patients with newly diagnosed, nonmetastatic brain stem glioma or high-grade glioma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pediatric Brain Tumor Consortium
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine

Criteria

DISEASE CHARACTERISTICS:

• One of the following newly diagnosed, nondisseminated brain tumors:

• Intrinsic infiltrating brain stem glioma

• Histopathologic diagnosis not required

• Histopathologically confirmed high-grade glioma, meeting all of the following criteria:

• Underwent prior definitive surgery ≤ 28 days ago with incompletely resected disease

• Any of the following subtypes allowed:

• Anaplastic astrocytoma

• Glioblastoma multiforme

• Other high-grade glioma

• No anaplastic oligodendroglioma

PATIENT CHARACTERISTICS:

• Karnofsky performance scale (PS) 50-100% (if > 16 years of age) or Lansky PS 50-100% (if ≤ 16 years of age)

• Absolute neutrophil count ≥ 1,000/mm³

• Platelet count ≥ 100,000/mm³ (transfusion independent)

• Hemoglobin ≥ 8 g/dL (transfusion independent)

• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age as follows:

• No more than 0.8 mg/dL (for patients 5 years of age and under)

• No more than 1 mg/dL (for patients 6-10 years of age)

• No more than 1.2 mg/dL (for patients 11-15 years of age)

• No more than 1.5 mg/dL (for patients over 15 years of age)

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

• ALT ≤ 5 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No uncontrolled infection

• No significant cardiac, hepatic, gastrointestinal, renal, pulmonary, or other systemic disease

• No known hypersensitivity to capecitabine or any of its components

• No known dihydropyrimidine dehydrogenase (DPD) deficiency

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Prior dexamethasone and/or surgery allowed

• No prior chemotherapy, radiotherapy, immunotherapy, or bone marrow transplantation

• No other concurrent anticancer or experimental drug therapies or agents

• No concurrent warfarin or sorivudine or its chemically related analogues (e.g., brivudine)