Abstract | PURPOSE: 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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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 |
Journal | Journal of neuro-oncology
(J Neurooncol)
Vol. 91
Issue 2
Pg. 175-82
(Jan 2009)
ISSN: 0167-594X [Print] United States |
PMID | 18797818
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Interferon Inducers
- Polylysine
- poly ICLC
- Carboxymethylcellulose Sodium
- Poly I-C
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Topics |
- Adult
- Aged
- Carboxymethylcellulose Sodium
(analogs & derivatives, therapeutic use)
- Disease-Free Survival
- Female
- Follow-Up Studies
- Glioblastoma
(therapy)
- Humans
- Interferon Inducers
(therapeutic use)
- Male
- Middle Aged
- Poly I-C
(therapeutic use)
- Polylysine
(analogs & derivatives, therapeutic use)
- Radiotherapy
(methods)
- Supratentorial Neoplasms
(therapy)
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