CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
bortezomib + temozolomide+ radiation therapydrug
Likely dose
bortezomib + temozolomide+ radiation therapy 1.3 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00998010
NCT00998010Phase 2Completed

Phase II Trial of Velcade (Bortezomib) in Combination With Temozolomide and Regional Radiation Therapy for Upfront Treatment of Patients With Newly-diagnosed Glioblastoma Multiforme

Jonsson Comprehensive Cancer Center·interventional·Posted Oct 20, 2009·Updated Aug 28, 2020

In Brief

A Phase 2 clinical trial evaluating bortezomib + temozolomide+ radiation therapy for Brain and Central Nervous System Tumors. Completed, enrolled 24 participants across 1 site.

Detailed Summary

RATIONALE: Bortezomib 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. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bortezomib together with temozolomide and radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started. PURPOSE: This phase II trial is studying the side effects and how well bortezomib works when given together with temozolomide and regional radiation therapy in treating patients with newly diagnosed glioblastoma multiforme or gliosarcoma.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 20, 2009
Enrollment StartOct 3, 2011
Primary CompletionMar 29, 2016
Study CompletionApr 20, 2018
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 16.7 years ago

Interventions

bortezomib + temozolomide+ radiation therapydrug

Patients will be treated with Bortezomib at 1.3 mg/m2 IV on days1,4,8,11,29,32,36 and 39 and Temozolomide on 75mg/m2 daily during radiation. External beam fractionated regional radiation will be given on consecutive week days at 200 centigray (cGy) daily doses to a total dose of 6000 cGy.