Gefitinib and Radiation Therapy in Treating Children With Newly Diagnosed Gliomas

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

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Gefitinib

Criteria

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