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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)

  • Clinial Study - Patient Studies
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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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Acknowledgment

We would like to thank Oncovir Inc. for their support of this trial.

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Authors and Affiliations

  1. Department of Neurological Surgery, University of California San Francisco, 400 Parnassus Avenue, A808, San Francisco, CA, 94143-0350, USA

    Nicholas Butowski, Susan M. Chang, Kathleen R. Lamborn & Michael D. Prados

  2. Department of Neurology, University of Michigan, 1500 East Medical Center Drive, Room 1914, Ann Arbor, MI, 48109-5316, USA

    Larry Junck

  3. Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY, 10021, USA

    Lisa M. DeAngelis & Lauren Abrey

  4. Baylor University, 3600 Gaston Avenue, Barnett Tower, Suite 605, Dallas, TX, 75246, USA

    Karen Fink

  5. University of California, Los Angles, 710 Westwood Plaza, Suite 1-230, Los Angeles, CA, 90095, USA

    Tim Cloughesy

  6. Oncovir, Inc., 3203 Cleveland Ave, NW, Washington, DC, 20008, USA

    Andres M. Salazar

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  1. Nicholas Butowski
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Correspondence to Nicholas Butowski.

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Butowski, N., Chang, S.M., Junck, L. et al. 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). J Neurooncol 91, 175–182 (2009). https://doi.org/10.1007/s11060-008-9693-3

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  • DOI: https://doi.org/10.1007/s11060-008-9693-3

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