CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 118 enrolled
Drug / intervention
Motexafin Gadolinium +2 moredrug
Likely dose
Not stated in 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/NCT00305864
NCT00305864Phase 2Completed

A PHASE I/II TRIAL OF TEMOZOLOMIDE, MOTEXAFIN GADOLINIUM, AND 60 GY FRACTIONATED RADIATION FOR NEWLY DIAGNOSED SUPRATENTORIAL GLIOBLASTOMA MULTIFORME

National Cancer Institute (NCI)·interventional·Posted Mar 22, 2006·Updated Mar 5, 2018

In Brief

A Phase 2 clinical trial evaluating 3-Dimensional Conformal Radiation Therapy, Motexafin Gadolinium, and 1 other intervention for Adult Giant Cell Glioblastoma and 2 related conditions. Completed, enrolled 118 participants across 106 sites.

Detailed Summary

This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed supratentorial glioblastoma multiforme or gliosarcoma. 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. Motexafin gadolinium may help temozolomide work better by making tumor cells more sensitive to the drug. Radiation therapy uses high-energy x-rays to kill tumor cells. Motexafin gadolinium may also make tumor cells more sensitive to radiation therapy. Giving motexafin gadolinium together with temozolomide and radition therapy may kill more tumor cells.

Study Details

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

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 22, 2006
Enrollment StartFeb 9, 2006
Primary CompletionFeb 16, 2011
Study CompletionMar 15, 2011
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 20.3 years ago

Interventions

3-Dimensional Conformal Radiation Therapyradiation

Undergo radiotherapy

Motexafin Gadoliniumdrug

Given IV

Temozolomidedrug

Given orally