A North American brain tumor consortium phase II study of poly-ICLC for adult patients with recurrent anaplastic gliomas Journal Article
| Authors: | Butowski, N.; Lamborn, K. R.; Lee, B. L.; Prados, M. D.; Cloughesy, T.; Deangelis, L. M.; Abrey, L.; Fink, K.; Lieberman, F.; Mehta, M.; Ian Robins, H.; Junck, L.; Salazar, A. M.; Chang, S. M. |
| Article Title: | A North American brain tumor consortium phase II study of poly-ICLC for adult patients with recurrent anaplastic gliomas |
| 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. © Springer Science+Business Media, LLC. 2008. |
| Keywords: | adult; clinical article; treatment outcome; aged; disease-free survival; middle aged; clinical trial; drug tolerability; fatigue; adjuvant therapy; disease free survival; temozolomide; glioma; brain neoplasms; magnetic resonance imaging; multiple cycle treatment; phase 2 clinical trial; neoplasm recurrence, local; myalgia; carmustine; survival time; disease progression; tumor recurrence; glioblastoma; cancer relapse; radiation therapy; poly-iclc; carboxymethylcellulose polycytidylic polyinosinic acid polylysine; injection site pain; open study; carboxymethylcellulose; interferon inducers; poly i-c; polylysine; anaplastic glioma; oligodendroglioma |
| Journal Title: | Journal of Neuro-Oncology |
| Volume: | 91 |
| Issue: | 2 |
| ISSN: | 0167-594X |
| Publisher: | Springer |
| Date Published: | 2009-01-01 |
| Start Page: | 183 |
| End Page: | 189 |
| Language: | English |
| DOI: | 10.1007/s11060-008-9705-3 |
| PUBMED: | 18850068 |
| PROVIDER: | scopus |
| PMCID: | PMC3104130 |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 14" - "Export Date: 30 November 2010" - "CODEN: JNODD" - "Source: Scopus" |
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