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Phase II study of temozolomide, thalidomide, and celecoxib for newly diagnosed glioblastoma in adults


Posted on: 04/20/2008

Link: http://neuro-oncology.dukejournals.org/cgi/content/abstract/15228517-2008-005v1?papetoc

First published on April 10, 2008
Neuro Oncol 2008, DOI:10.1215/15228517-2008-005

© Copyright 2008 by the Society for Neuro-Oncology

Received December 28, 2006
Accepted May 24, 2007

Clinical Investigations

Phase II study of temozolomide, thalidomide, and celecoxib for newly diagnosed glioblastoma in adults

Santosh Kesari 1, David Schiff 2, John W. Henson 3, Alona Muzikansky 4, Debra C. Gigas 5, Lisa Doherty 5, Tracy T. Batchelor 3, Janina A. Longtine 6, Keith L. Ligon 6, Susan Weaver 7, Andrea Laforme 8, Naren Ramakrishna 9, Peter McL. Black 10, Jan Drappatz 1, Abigail Ciampa 5, Judah Folkman 11, Mark Kieran 12, Patrick Y. Wen 1*

1 Dana-Farber/Brigham and Women's Cancer Center, Center for Neuro-Oncology, Boston, MA, USA; Department of Neurology, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA
2 Neuro-Oncology Center, University of Virginia, Charlottesville, VA, USA
3 Harvard Medical School, Boston, MA, USA; Stephen E. and Catherine Pappas Center for Neuro-Oncology, Massachusetts General Hospital, Boston, MA, USA
4 Harvard Medical School, Boston, MA, USA; Massachusetts General Hospital, Boston, MA, USA
5 Dana-Farber/Brigham and Women's Cancer Center, Center for Neuro-Oncology, Boston, MA, USA
6 Department of Pathology, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA
7 Albany Medical Center, Albany, NY, USA
8 Division of Pediatric Oncology, Dana-Farber Cancer Institute and Children's Hospital, Boston, MA, USA; Department of Surgery, Vascular Biology Program, Children's Hospital, Boston, MA, USA
9 Dana-Farber/Brigham and Women's Cancer Center, Center for Neuro-Oncology, Boston, MA, USA; Department of Radiation Oncology, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA
10 Dana-Farber/Brigham and Women's Cancer Center, Center for Neuro-Oncology, Boston, MA, USA; Department of Neurosurgery, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA
11 Harvard Medical School, Boston, MA, USA; Department of Surgery, Vascular Biology Program, Children's Hospital, Boston, MA, USA
12 Harvard Medical School, Boston, MA, USA; Division of Pediatric Oncology, Dana-Farber Cancer Institute and Children's Hospital, Boston, MA, USA; Department of Surgery, Vascular Biology Program, Children's Hospital, Boston, MA, USA

 

* To whom correspondence should be addressed. E-mail: pwen@partners.org .


   Abstract

We conducted a phase II study of the combination of temozolomide and angiogenesis inhibitors for treating adult patients with newly diagnosed glioblastoma. Patients who had stable disease following standard radiation therapy received temozolomide for 5 days in 28-day cycles, in combination with daily thalidomide and celecoxib. Patients were treated until tumor progression or development of unacceptable toxicity. Four-month progression-free survival (PFS) from study enrollment was the primary end point, and overall survival (OS) was the secondary end point. In addition, we sought to correlate response with O6-methylguanine-DNA methyltransferase promoter methylation status and serum levels of angiogenic peptides. Fifty patients with glioblastoma were enrolled (18 women, 32 men). Median age was 54 years (range, 29-78) and median KPS score was 90 (range, 70-100). From study enrollment, median PFS was 5.9 months (95% confidence interval [CI]: 4.2-8.0) and 4-month PFS was 63% (95% CI: 46%-75%). Median OS was 12.6 months (95% CI: 8.5-16.4) and 1-year OS was 47%. Of the 47 patients evaluable for best response, none had a complete response, five (11%) had partial response, four (9%) had minor response, 22 (47%) had stable disease, and 16 (34%) had progressive disease. Analysis of serial serum samples obtained from 47 patients for four angiogenic peptides failed to show a significant correlation with response or survival for three of the peptides; higher vascular endothelial growth factor levels showed a trend toward correlation with decreased OS (p = 0.07) and PFS (p = 0.09). The addition of celecoxib and thalidomide to adjuvant temozolomide was well tolerated but did not meet the primary end point of improvement of 4-month PFS from study enrollment.

Key Words: angiogenesis, chemotherapy, clinical trial, glioblastoma


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