Gefitinib and Radiation Therapy in Treating Children With Newly Diagnosed Gliomas

Completed · Phase 1/Phase 2

Conditions studied: Untreated Childhood Anaplastic Astrocytoma, Untreated Childhood Anaplastic Oligodendroglioma, Untreated Childhood Brain Stem Glioma, Untreated Childhood Giant Cell Glioblastoma, Untreated Childhood Glioblastoma, Untreated Childhood Gliomatosis Cerebri, Untreated Childhood Gliosarcoma, Untreated Childhood Oligodendroglioma

In brief

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.

Key facts

Study ID: NCT00042991
Run by: National Cancer Institute (NCI)
People needed: 69
Starts: 2002-07-01
Expected to finish: 2010-03-01
Last updated by the study team: 2014-05-28

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Pediatric Brain Tumor Consortium — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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