Clinical trial · Interventional
Capecitabine and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Nonmetastatic Brain Stem Glioma or High-Grade Glioma
A Phase I Trial of Capecitabine Rapidly Disintegrating Tablets and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas and High Grade Gliomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose of capecitabine rapidly disintegrating tablets (RDT) in combination with radiotherapy
- timeFrame
- First 11 weeks of therapy
- measure
- Dose-limiting toxicity
- timeFrame
- First 11 weeks of therapy
Secondary outcomes (4)
- measure
- Pharmacokinetics of capecitabine RDT measured periodically during course 1
- timeFrame
- Day 1 and Day 14 of therapy
- measure
- Tumor response
- timeFrame
- From day 1 of treatment until off study
- description
- Brain imaging to assess tumor response to the treatment is performed at baseline, week 11, end of course 6, and then every 3 months for two years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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)References
Publications (0)
Data not yet available