Journal
JOURNAL OF NEURO-ONCOLOGY
Volume 91, Issue 2, Pages 183-189Publisher
SPRINGER
DOI: 10.1007/s11060-008-9705-3
Keywords
Anaplastic glioma; Radiation therapy; Adjuvant therapy; Poly-ICLC
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Funding
- NCATS NIH HHS [UL1 TR000005] Funding Source: Medline
- NCI NIH HHS [U01 CA062421, U01 CA062421-08] Funding Source: Medline
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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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