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01-01-2009 | Clinial Study - Patient Studies

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)

Authors: Nicholas Butowski, Susan M. Chang, Larry Junck, Lisa M. DeAngelis, Lauren Abrey, Karen Fink, Tim Cloughesy, Kathleen R. Lamborn, Andres M. Salazar, Michael D. Prados

Published in: Journal of Neuro-Oncology | Issue 2/2009

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.

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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)
Authors: Nicholas Butowski
Susan M. Chang
Larry Junck
Lisa M. DeAngelis
Lauren Abrey
Karen Fink
Tim Cloughesy
Kathleen R. Lamborn
Andres M. Salazar
Michael D. Prados
Publication date: 01-01-2009
Publisher: Springer US
Published in: Journal of Neuro-Oncology / Issue 2/2009
Print ISSN: 0167-594X
Electronic ISSN: 1573-7373
DOI: https://doi.org/10.1007/s11060-008-9693-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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