CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 69 enrolled
Drug / intervention
gefitinib +3 moredrug
Likely dose
Gefitinib orally (specific dose not stated in trial record)AI-extracted
Key inclusion· 6
  • ✓Newly diagnosed non-disseminated diffuse intrinsic brainstem tumor (Phase I and II) OR newly diagnosed incompletely resected supratentorial malignant glioma with residual tumor on postoperative imaging (Phase I only)
  • ✓Karnofsky or Lansky performance status ≥50% assessed within two weeks prior to registration
  • ✓No prior chemotherapy, including gefitinib
  • ✓No prior radiation therapy
Key exclusion· 8
  • ✕Evidence of intramural hemorrhage on scan prior to or after enrollment before treatment
  • ✕Brain stem glioma patients taking enzyme-inducing anticonvulsant drugs (EIACD)
  • ✕Any other anticancer or experimental drug therapy
  • ✕Uncontrolled infection

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

Search/NCT00042991
NCT00042991Phase 2Completed
CompareCT.gov

Phase I/II Trial of Gefitinib and Radiation in Pediatric Patients Newly Diagnosed With Brain Stem Tumors or Incompletely Resected Supratentorial Malignant Gliomas With Phase II Limited to Brain Stem Tumors

National Cancer Institute (NCI)·interventional·Posted Jan 27, 2003·Updated May 28, 2014

In Brief

A Phase 2 clinical trial evaluating gefitinib, radiation therapy, and 2 other interventions for Untreated Childhood Anaplastic Astrocytoma and 7 related conditions. Completed, enrolled 69 participants across 1 site.

Detailed Summary

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.

Study Details

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

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartJul 1, 2002
Primary CompletionFeb 1, 2010
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 23.4 years ago

Interventions

gefitinibdrug

Given orally

radiation therapyradiation

Undergo standard brain irradiation

pharmacological studyother

Correlative studies

laboratory biomarker analysisother

Correlative studies