Clinical trial · Interventional
Gefitinib and Radiation Therapy in Treating Children With Newly Diagnosed Gliomas
Phase I/II Trial of Gefitinib and Radiation in Pediatric Patients Newly Diagnosed With Brain Stem Tumors or Incompletely Resected Supratentorial Malignant Gliomas With Phase II Limited to Brain Stem Tumors
NCT00042991CI-TRIAL-00014711completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Biological therapies such as gefitinib may interfere with the growth of the tumor cells and may make the tumor cells more sensitive to radiation therapy. This phase I/II trial is studying how well giving gefitinib together with radiation therapy works in treating children with newly diagnosed glioma.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Untreated Childhood Anaplastic Astrocytoma | Childhood Anaplastic Astrocytoma | CURATED_BROADER | 0.80 |
| Untreated Childhood Anaplastic Oligodendroglioma | Childhood Anaplastic Oligodendroglioma | CURATED_BROADER | 0.78 |
| Untreated Childhood Brain Stem Glioma | Childhood Brain Stem Glioma | CURATED_BROADER | 0.78 |
| Untreated Childhood Giant Cell Glioblastoma | Childhood Giant Cell Glioblastoma | CURATED_BROADER | 0.78 |
| Untreated Childhood Glioblastoma | Childhood Glioblastoma | CURATED_BROADER | 0.78 |
| Untreated Childhood Gliomatosis Cerebri | Childhood Gliomatosis Cerebri | CURATED_BROADER | 0.78 |
| Untreated Childhood Gliosarcoma | Childhood Gliosarcoma | CURATED_BROADER | 0.78 |
| Untreated Childhood Oligodendroglioma | Childhood Oligodendroglioma |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (gefitinib and radiation therapy)
- description
- Phase I portion: Patients receive oral gefitinib once daily. Treatment repeats every 4 weeks for 13 courses (1 year). Patients also receive standard brain irradiation once daily, 5 days a week, for 6 weeks beginning concurrently with initiation of the first course of gefitinib. Treatment continues in the absence of disease progression or unacceptable toxicity. Phase II portion: Once the MTD or the recommended Phase-II dose is determined, additional patients who have newly diagnosed BSG are treated at the MTD or the recommended Phase-II dose.
- interventionNames
- Drug: gefitinib
- Radiation: radiation therapy
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (3)
- measure
- Number of Participants in Phase I Stratum 1A With Dose-limiting Toxicities (DLT) Observed During the First 8 Weeks of Gefitinib Therapy
- timeFrame
- Day 1 of gefitinib therapy to end of week 8
- description
- The dose limiting toxicity (DLT) analysis population consists of stratum 1A phase I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (course 1 and 2) or who completed the MTD estimation period without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD based on the tradional 3+3 design, where a dose is considered a safe dose only when 0 out of 3, or at most 1 out of 6 patients has DLTs. When two or more patients in a group of 2 to 6 patients had DLTs, then that dose level was considered to be too toxic.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Tumor: * Phase I: newly diagnosed non-disseminated diffuse intrinsic brainstem tumor or newly diagnosed (diagnostic scan must be within 4 weeks prior to treatment initiation), incompletely resected supratentorial malignant glioma (anaplastic astrocytoma, glioblastoma multiforme or other high-grade glioma) (STMG); the STMG group must have residual tumor evident on postoperative MRI or CT * Phase II: only newly diagnosed non-disseminated diffuse intrinsic brain stem glioma patients are eligible * Performance status: Karnofsky or Lansky \>= 50% assessed within two weeks prior to registration * Prior/concurrent therapy: * Chemotherapy: no prior therapy allowed, including prior gefitinib treatment * Radiation therapy (XRT): no prior therapy allowed * Bone marrow transplant: none prior * Anti-convulsants: patients with brain stem glioma (BSG) receiving EIACD will not be eligible; patients with STMG will be eligible for this study even if they are receiving enzyme inducting anti-convulsant drugs (EIACD) and will be stratified by use of EIACDs * Growth factors: off all colony forming growth factor(s) \> 2 weeks prior to registration (G-CSF, GM-CSF, erythropoietin) * ANC \> 1,000/ul * Platelets \> 100,000/ul (transfusion independent) * Hemoglobin \> 8g/dl (may be transfused) * Patients may have bone marrow involvement by disease * Creatinine \< 2 x normal for age or GFR \> 70 ml/min/1.73m\^2 * Bilirubin \< 1.5 x normal institutional normal for age * SGPT (ALT) \< 3 x institutional normal for age * Pregnant and/or lactating patients are excluded; patients of childbearing potential should not become pregnant and should not father a child during treatment with gefitinib; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method * Signed informed consent according to institutional guidelines must be obtained prior to study entry Exclusion Criteria: * Patients with evidence of intramural hemorrhage on a scan obtained prior to enrollment or after enrollment, before treatment * Patients with BSG must not be taking enzyme-inducing anticonvulsant drugs * Patient must not be receiving any other anticancer or experimental drug therapy * Patient must have no uncontrolled infection * Patients with significant cardiac, hepatic, gastrointestinal, renal, pulmonary, or psychiatric disease are ineligible; patients with deep venous or arterial thrombosis within 6 weeks of study entry are ineligible * Patients with disseminated disease are not permitted * Patients with spinal disease requiring craniospinal radiation are not eligible * Patients with completely resected supratentorial malignant gliomas patients are ineligible
References
Publications (0)
Data not yet available
No reference posted for this study.