Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma
Untreated Childhood Brain Stem Glioma
About this trial
This is an interventional treatment trial for Untreated Childhood Brain Stem Glioma
Eligibility Criteria
Inclusion Criteria: Newly diagnosed non-disseminated intrinsic diffuse brainstem glioma Karnofsky performance scale (KPS) (for > 16 yrs of age) or Lansky performance score (LPS) (for =< 16 years of age) => 50 assessed within two weeks prior to registration Prior/concurrent therapy: Chemo: No prior therapy allowed Radiation therapy (XRT): No prior therapy allowed Bone Marrow Transplant: None prior Anti-convulsants: Patients receiving EIACDs will not be eligible; however, patients may switch from EIACDs to non-EIACDs and must then be on non-EIACDs for a minimum of 7 days prior to registration Growth factors: Off all colony forming growth factor(s) > 2 weeks prior to registration (G-CSF, GM-CSF, erythropoietin) Absolute neutrophil count >= 1,000/mm^3 Platelets >= 100,000/mm^3 (transfusion independent) Hemoglobin >= 8 gm/dL (transfusion independent) Serum creatinine that is less than the upper limit of institutional normal for age or GFR > 70 ml/min/1.73m2 Bilirubin =< 1.5 time upper limit of normal for age SGPT (ALT) and SGOT (AST) < 2.5 times institutional upper limit of normal Female patients of childbearing potential must have negative serum or urine pregnancy test; patient must not be pregnant or breast-feeding Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study Signed informed consent according to institutional guidelines must be obtained Exclusion Criteria: Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy; patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism Patients with disseminated intrinsic diffuse brainstem glioma Patients taking enzyme-inducing anticonvulsant drugs Patients with known allergy to topical or systemic imidazoles (e.g., clotrimazole, ketoconazole, miconazole, econazole) Patients receiving any other anticancer or experimental drug therapy Patients with uncontrolled infection
Sites / Locations
- Pediatric Brain Tumor Consortium
Arms of the Study
Arm 1
Experimental
Treatment (radiation therapy and tipifarnib)
PHASE I: Patients undergo radiotherapy 5 days a week for 6 weeks. Beginning 0-2 days before radiotherapy, patients receive oral tipifarnib twice daily until the completion of radiotherapy. Beginning 2 weeks after the completion of radiotherapy, patients receive oral tipifarnib twice daily in weeks 1-3. Treatment repeats every 4 weeks for up to 24 additional courses (total of 26 courses) in the absence of disease progression or unacceptable toxicity. PHASE II: Patients undergo radiotherapy and receive tipifarnib at the MTD as in phase I (closed to accrual as of 1/19/06). Treatment continues for up to 24 months (26 courses) in the absence of disease progression or unacceptable toxicity.