Journal of Neuro-Oncology

, 91:175

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)

  • 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
Clinial Study - Patient Studies

DOI: 10.1007/s11060-008-9693-3

Cite this article as:
Butowski, N., Chang, S.M., Junck, L. et al. J Neurooncol (2009) 91: 175. doi:10.1007/s11060-008-9693-3

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.

Keywords

Glioblastoma multiformeRadiation therapyAdjuvant therapyPoly-ICLC

Copyright information

© Springer Science+Business Media, LLC. 2008

Authors and Affiliations

  • Nicholas Butowski
    • 1
  • Susan M. Chang
    • 1
  • Larry Junck
    • 2
  • Lisa M. DeAngelis
    • 3
  • Lauren Abrey
    • 3
  • Karen Fink
    • 4
  • Tim Cloughesy
    • 5
  • Kathleen R. Lamborn
    • 1
  • Andres M. Salazar
    • 6
  • Michael D. Prados
    • 1
  1. 1.Department of Neurological SurgeryUniversity of California San FranciscoSan FranciscoUSA
  2. 2.Department of NeurologyUniversity of MichiganAnn ArborUSA
  3. 3.Memorial Sloan-Kettering Cancer CenterNew YorkUSA
  4. 4.Baylor UniversityDallasUSA
  5. 5.University of California, Los AnglesLos AngelesUSA
  6. 6.Oncovir, Inc.WashingtonUSA