A phase II clinical trial of poly-ICLC with radiation for adult patients with newly diagnosed supratentorial glioblastoma: A North American Brain Tumor Consortium (NABTC01-05) Journal Article

   

Authors:	Butowski, N.; Chang, S. M.; Junck, L.; Deangelis, L. M.; Abrey, L.; Fink, K.; Cloughesy, T.; Lamborn, K. R.; Salazar, A. M.; Prados, M. D.
Article Title:	A phase II clinical trial of poly-ICLC with radiation for adult patients with newly diagnosed supratentorial glioblastoma: A North American Brain Tumor Consortium (NABTC01-05)
Abstract:	Purpose: This phase II study was designed to determine the overall survival time of adults with supratentorial glioblastoma treated with the immune modulator, polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (poly-ICLC), in combination with and following radiation therapy (RT). Methods and materials: This was an open-label, single arm phase II study. Patients were treated with RT in combination with poly-ICLC followed by poly-ICLC as a single agent. Poly-ICLC was initiated 7-28 days after the surgical procedure that established the diagnosis; radiotherapy began within 7 days of the first dose of poly-ICLC and within 35 days of surgical diagnosis. Treatment with poly-ICLC continued following the completion of RT to a maximum of 1 year or until tumor progression. Results: 31 patients were enrolled in this study. One patient did not have a Glioblastoma mutiforme and was deemed ineligible. For the 30 eligible patients, time to progression was known for 27 patients and 3 were censored. The estimated 6-month progression-free survival was 30% and the estimated 1-year progression-free survival was 5%. Median time to progression was as 18 weeks. The 1-year survival was 69% and the median survival was 65 weeks. Conclusions: The combined therapy was relatively well-tolerated. This study suggests a survival advantage compared to historical studies using RT without chemotherapy but no survival advantage compared to RT with adjuvant nitrosourea or non-temozolomide chemotherapy. Our results suggest that poly-ICLC has activity against glioblastoma and may be worth further study in combination with agents such as temozolomide. © Springer Science+Business Media, LLC. 2008.
Keywords:	adult; clinical article; controlled study; aged; disease-free survival; middle aged; overall survival; clinical trial; drug tolerability; fatigue; cancer growth; diarrhea; adjuvant therapy; cancer radiotherapy; disease free survival; follow-up studies; controlled clinical trial; phase 2 clinical trial; leukopenia; myalgia; radiotherapy; chill; drug fever; lymphocytopenia; survival time; rigor; thrombosis; glioblastoma; radiation therapy; glioblastoma multiforme; poly-iclc; carboxymethylcellulose polycytidylic polyinosinic acid polylysine; nitrosourea; injection site pain; open study; carboxymethylcellulose; interferon inducers; poly i-c; polylysine; supratentorial neoplasms
Journal Title:	Journal of Neuro-Oncology
Volume:	91
Issue:	2
ISSN:	0167-594X
Publisher:	Springer
Date Published:	2009-01-01
Start Page:	175
End Page:	182
Language:	English
DOI:	10.1007/s11060-008-9693-3
PUBMED:	18797818
PROVIDER:	scopus
PMCID:	PMC4779120
DOI/URL:	http://www.scopus.com/inward/record.url?eid=2-s2.0-57349153494&partnerID=40&md5=a5d30f6be51fcdf616505ea24f234517
Notes:	--- - "Cited By (since 1996): 13" - "Export Date: 30 November 2010" - "CODEN: JNODD" - "Source: Scopus"

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