CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
tipifarnib +1 moredrug
Likely dose
Tipifarnib orally (specific dose not stated)AI-extracted
Key inclusion· 7
  • Newly diagnosed non-disseminated intrinsic diffuse brainstem glioma
  • KPS ≥50 (age >16) or Lansky Performance Score ≥50 (age ≤16) within two weeks prior to registration
  • No prior chemotherapy
  • No prior radiation therapy
Key exclusion· 6
  • Disseminated intrinsic diffuse brainstem glioma
  • Currently taking enzyme-inducing anticonvulsant drugs
  • Known allergy to topical or systemic imidazoles (clotrimazole, ketoconazole, miconazole, econazole)
  • Receiving any other anticancer or experimental drug therapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00079339
NCT00079339Phase 2Completed

Phase I/II Trial of R115777 and XRT in Pediatric Patients With Newly Diagnosed Non-Disseminated Intrinsic Diffuse Brainstem Gliomas

National Cancer Institute (NCI)·interventional·Posted Mar 10, 2004·Updated May 15, 2014

In Brief

A Phase 2 clinical trial evaluating radiation therapy and tipifarnib for Untreated Childhood Brain Stem Glioma. Completed, enrolled 51 participants across 1 site.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 10, 2004
Enrollment StartJan 1, 2004
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 22.3 years ago

Interventions

radiation therapyradiation

Undergo radiotherapy

tipifarnibdrug

Given orally