Clinical trial · Interventional
Tipifarnib and Radiation Therapy in Treating Young Patients With Brainstem Glioma
Phase I/II Trial of R115777 and XRT in Pediatric Patients With Newly Diagnosed Non-Disseminated Intrinsic Diffuse Brainstem Gliomas
NCT00079339CI-TRIAL-00014530completedPhase 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)
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)
Conditions
Conditions (1)
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 Brain Stem Glioma | Childhood Brain Stem Glioma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
| tipifarnib | Drug | Tipifarnib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (radiation therapy and tipifarnib)
- description
- 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.
- interventionNames
- Radiation: radiation therapy
- Drug: tipifarnib
Primary outcomes (2)
- measure
- Number of Participants in the Phase I Component With Dose-limiting Toxicities (DLTs) Observed During the First 8 Weeks (Courses 1 and 2) of Tipifarnib Therapy
- timeFrame
- Day 1 of tipifarnib therapy to week 8
- description
- The dose limiting toxicity (DLT) analysis population consists of phase I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.