Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Tipifarnib may make tumor cells more sensitive to radiation therapy. Combining tipifarnib with radiation therapy may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of tipifarnib to see how well it works when given together with radiation therapy in treating young patients with newly diagnosed brain stem glioma. (Phase I closed to accrual as of 1/19/06)

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

Details

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

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