CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 118 enrolled
Drug / intervention
Lomustine +3 moredrug
Likely dose
Temozolomide (dose not specified in interventions) concurrent with radiation therapy, followed by temozolomide and CCNU (lomustine) given orallyAI-extracted
Key inclusion· 8
  • Histologically confirmed, newly diagnosed high-grade glioma: anaplastic astrocytoma, glioblastoma multiforme, or gliosarcoma
  • Primary spinal cord malignant gliomas are allowed
  • Surgical resection or biopsy of tumor within past 31 days
  • Pre-operative and post-operative brain MRI with and without gadolinium-contrast (or spine MRI for spinal cord primaries)
Key exclusion· 7
  • Primary brainstem tumors
  • Hypersensitivity to temozolomide
  • Prior biologic agents or chemotherapy
  • Concurrent corticosteroids as antiemetic (allowed only for increased intracranial pressure)

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

Search/NCT00100802
NCT00100802Phase 2Completed

A Phase II Study of Concurrent Radiation and Temozolomide Followed By Temozolomide and CCNU in the Treatment of Children With High-Grade Glioma

Children's Oncology Group·interventional·Posted Jan 7, 2005·Updated Feb 15, 2023

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis, Lomustine, and 2 other interventions for Anaplastic Astrocytoma and 4 related conditions. Completed, enrolled 118 participants across 1 site.

Detailed Summary

This phase II trial is studying how well giving radiation therapy together with temozolomide and lomustine works in treating young patients with newly diagnosed gliomas. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide and lomustine after surgery may kill any remaining tumor cells.

Study Details

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

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 7, 2005
Enrollment StartMar 21, 2005
Primary CompletionSep 1, 2012
Study CompletionJun 30, 2017
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 21.5 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

Lomustinedrug

Given PO

Radiation Therapyradiation

Undergo radiation therapy

Temozolomidedrug

Given PO