Document Detail


A North American brain tumor consortium (NABTC 99-04) phase II trial of temozolomide plus thalidomide for recurrent glioblastoma multiforme.
MedLine Citation:
PMID:  17031561     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Laboratory and clinical data suggest that the anti-angiogenic agent, thalidomide, if combined with cytotoxic agents, may be effective against recurrent glioblastoma multiforme (GBM). OBJECTIVES: To determine 6-month progression-free survival (6PFS) and toxicity of temozolomide plus thalidomide in adults with recurrent GBM. PATIENTS AND METHODS: Eligible patients had recurrent GBM after surgery, radiotherapy, and/or adjuvant chemotherapy. Temozolomide was given at 150-200 mg/m(2)/day on days 1-5 of each 28-day cycle. Thalidomide was given orally at 400 mg at bedtime (days 1-28) and increased to 1,200 mg as tolerated. Patients were evaluated with magnetic resonance imaging scans every 56 days. The study was designed to detect an increase of the historical 6PFS for GBM from 10 to 30%. RESULTS: Forty-four patients were enrolled, 43 were evaluable for efficacy and safety. The study population included 15 women, 29 men; median age was 53 years (range 32-84); median Karnofsky performance status was 80% (range 60-100%). Thirty-six (82%) patients were chemotherapy-naïve. There were 57 reports of toxicity of grade 3 or greater. Non-fatal grade 3-4 granulocytopenia occurred in 15 patients (34%). The objective response rate was 7%. The estimated probability of being progression-free at 6 months with this therapy is 24% [95% confidence interval (C.I.) 12-38%]. The median time to progression is 15 weeks (95% C.I. 10-20 weeks). There was no observed correlation between serum levels of vascular endothelial growth factor, basic fibroblast growth factor, and IL-8 and the 6PFS outcome. CONCLUSION: This drug combination was reasonably safe, but with little indication of improvement compared to temozolomide alone.
Authors:
Morris D Groves; Vinay K Puduvalli; Susan M Chang; Charles A Conrad; Mark R Gilbert; Ivo W Tremont-Lukats; Ta-Jen Liu; Pamela Peterson; David Schiff; Timothy F Cloughesy; Patrick Y Wen; Harry Greenberg; Lauren E Abrey; Lisa M DeAngelis; Kenneth R Hess; Kathleen R Lamborn; Michael D Prados; W K Alfred Yung
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Research Support, N.I.H., Extramural     Date:  2006-09-22
Journal Detail:
Title:  Journal of neuro-oncology     Volume:  81     ISSN:  0167-594X     ISO Abbreviation:  J. Neurooncol.     Publication Date:  2007 Feb 
Date Detail:
Created Date:  2007-01-22     Completed Date:  2007-04-05     Revised Date:  2007-12-03    
Medline Journal Info:
Nlm Unique ID:  8309335     Medline TA:  J Neurooncol     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  271-7     Citation Subset:  IM    
Affiliation:
Department of Neuro-Oncology, The University of Texas MD Anderson Cancer Center, 1400 Holcombe, 431, Houston, TX, 77030, USA. mgroves@mdanderson.org
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
Brain Neoplasms / drug therapy*,  mortality
Dacarbazine / analogs & derivatives,  therapeutic use
Disease-Free Survival
Enzyme-Linked Immunosorbent Assay
Female
Glioblastoma / drug therapy*,  mortality
Humans
Male
Middle Aged
Neoplasm Recurrence, Local / drug therapy*
North America
Survival Analysis
Thalidomide / therapeutic use
Grant Support
ID/Acronym/Agency:
CA16672/CA/NCI NIH HHS; CA62399/CA/NCI NIH HHS; CA62412/CA/NCI NIH HHS; CA62422/CA/NCI NIH HHS; M01-RR00042/RR/NCRR NIH HHS; M01-RR00056/RR/NCRR NIH HHS; M01-RR00079/RR/NCRR NIH HHS; M01-RR0865/RR/NCRR NIH HHS; U01CA62405/CA/NCI NIH HHS; U01CA62407/CA/NCI NIH HHS
Chemical
Reg. No./Substance:
4342-03-4/Dacarbazine; 50-35-1/Thalidomide; 85622-93-1/temozolomide

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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