CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
Erlotinib hydrochloridedrug
Likely dose
Erlotinib given once daily during and after conventionally fractionated radiotherapy for 8 weeks, followed by continuous administration for up to 3 years (specific dose not stated)AI-extracted
Key inclusion· 8
  • ✓Histologically confirmed high-grade glioma (WHO grade III or IV) including anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma multiforme, or other specified subtypes
  • ✓Unfavorable low-grade glioma with gliomatosis cerebri or bithalamic involvement
  • ✓Newly diagnosed disease
  • ✓Intracranial or spinal cord tumors allowed
Key exclusion· 8
  • ✕Prior or concurrent biologic agents
  • ✕Prior or concurrent chemotherapy
  • ✕Prior radiotherapy
  • ✕Other prior or concurrent anticancer or experimental treatment

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

Search/NCT00124657
NCT00124657Phase 2Completed
CompareCT.gov

A Phase I/II Trial of a New Tyrosine Kinase Inhibitor (Tarceva; Erlotinib Hydrochloride; OSI-774) During and After Radiotherapy in the Treatment of Patients With Newly Diagnosed High Grade Glioma and Unfavorable Low-Grade Glioma

St. Jude Children's Research Hospital·interventional·Posted Jul 28, 2005·Updated Dec 4, 2015

In Brief

A Phase 2 clinical trial evaluating Erlotinib hydrochloride for Brain and Central Nervous System Tumors. Completed, enrolled 62 participants across 3 sites.

Detailed Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It may also make tumor cells more sensitive to radiation therapy. Giving radiation therapy together with erlotinib may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of erlotinib when given together with radiation therapy and to see how well they work in treating young patients with newly diagnosed glioma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain and Central Nervous System Tumors
CountriesUnited States
CollaboratorsRady Children's Hospital, San Diego, Duke University

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 28, 2005
Enrollment StartMar 1, 2005
Primary CompletionJul 1, 2012
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 20.9 years ago

Interventions

Erlotinib hydrochloridedrug

This study has 2 components: a Phase I component which estimated the MTD and DLT(s) of erlotinib given once a day during and after conventionally fractionated RT for a period of 8 weeks (DLT-evaluation period), followed by continuous administration of this medication for up to 3 years; and a Phase II component where erlotinib will be given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study is 120mg/m2 per day (maximum dose of 200mg per day).