Status:
COMPLETED
Capecitabine and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Nonmetastatic Brain Stem Glioma or High-Grade Glioma
Lead Sponsor:
Pediatric Brain Tumor Consortium
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
3-21 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
OBJECTIVES: Primary * Estimate the maximum tolerated dose of capecitabine rapidly disintegrating tablets (RDT) administered concurrently with radiotherapy in young patients with newly diagnosed, non...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00357253
Start Date
January 1 2006
End Date
March 1 2010
Last Update
January 10 2013
Active Locations (12)
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1
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010-2970
3
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614
4
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182