Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Phase 2 Completed Dana-Farber Cancer Institute National Cancer Institute (NCI) · collab

Open-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may increase the effectiveness of temozolomide by making tumor cells more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combining temozolomide, thalidomide, and celecoxib following radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

Timeline

Start: 2001-04
Primary completion: 2005-03
Completion: 2007-09

Outcome

Missed primary endpoint

paper did not meet the primary end point of improvement of 4-month PFS from study enrollment. PMID 18403492 ↗

Publications

Results Kesari S, Schiff D, Henson JW, Muzikansky A, Gigas DC, Doherty L, Batchelor TT, Longtine JA, Ligon KL, Weaver S, Laforme A, Ramakrishna N, Black PM, Drappatz J, Ciampa A, Folkman J, Kieran M, Wen PY. Phase II study of temozolomide, thalidomide, and celecoxib for newly diagnosed glioblastoma in adults. Neuro Oncol. 2008 Jun;10(3):300-8. doi: 10.1215/15228517-2008-005. Epub 2008 Apr 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Celecoxib	Other / unclassified	—	Oral
Subject	Temozolomide	Small molecule	—	Oral
Subject	Thalidomide	Other / unclassified	—	Oral