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A North American brain tumor consortium phase II study of poly-ICLC for adult patients with recurrent anaplastic gliomas

  • Clinical study - patient study
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Abstract

This phase II study was designed to determine the objective response rate and 6-month progression free survival of adult patients with recurrent supratentorial anaplastic glioma when treated with the immune modulator, polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (poly-ICLC). This was an open-labeled, single arm phase II study. Patients were treated with poly-ICLC alone. Patients may have had treatment for no more than two prior relapses. Treatment with poly-ICLC continued until tumor progression. Fifty five patients were enrolled in the study. Ten were ineligible after central review of pathology. Eleven percent of patients (5 of 45) had a radiographic response. Time to progression was known for 39 patients and 6 remain on treatment. The estimated 6-month progression free survival was 24%. The median survival time was 43 weeks. Poly-ICLC was well tolerated, but there was no improvement in 6-month progression free survival compared to historical database nor was there an encouraging objective radiographic response rate. Based on this study, poly-ICLC does not improve 6moPFS in patients with recurrent anaplastic gliomas but may be worth further study in combination with agents such as temozolomide.

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Acknowledgement

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

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

  2. San Jose State University, One Washington Sq., San Jose, CA, 95192, USA

    Bee L. Lee

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

    Timothy Cloughesy

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

    Lisa M. DeAngelis & Lauren Abrey

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

    Karen Fink

  6. University of Pittsburgh Cancer Pavilion, 5th Floor, 5150 Centre Ave., Pittsburgh, PA, 15232, USA

    Frank Lieberman

  7. University of Wisconsin, 600 Highland Avenue, Madison, WI, 53792, USA

    Minesh Mehta & H. Ian Robins

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

    Larry Junck

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

    Andres M. Salazar

Authors
  1. Nicholas Butowski
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  2. Kathleen R. Lamborn
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  3. Bee L. Lee
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  4. Michael D. Prados
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  5. Timothy Cloughesy
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  6. Lisa M. DeAngelis
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  7. Lauren Abrey
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  8. Karen Fink
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  9. Frank Lieberman
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  10. Minesh Mehta
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  11. H. Ian Robins
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  12. Larry Junck
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  13. Andres M. Salazar
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  14. Susan M. Chang
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Correspondence to Nicholas Butowski.

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Butowski, N., Lamborn, K.R., Lee, B.L. et al. A North American brain tumor consortium phase II study of poly-ICLC for adult patients with recurrent anaplastic gliomas. J Neurooncol 91, 183–189 (2009). https://doi.org/10.1007/s11060-008-9705-3

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  • DOI: https://doi.org/10.1007/s11060-008-9705-3

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