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.

• Authors: Nicholas Butowski, Kathleen R Lamborn, Bee L Lee, Michael D Prados, Timothy Cloughesy, Lisa M DeAngelis, Lauren Abrey, Karen Fink, Frank Lieberman, Minesh Mehta, H Ian Robins, Larry Junck, Andres M Salazar, Susan M Chang
• Journal: Journal of neuro-oncology (J Neurooncol) Vol. 91 Issue 2 Pg. 183-9 (Jan 2009) ISSN: 0167-594X [Print] United States
• PMID: 18850068 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Interferon Inducers
• Polylysine
• poly ICLC
• Carboxymethylcellulose Sodium
• Poly I-C

Topics

• Adult
• Aged
• Brain Neoplasms (pathology, therapy)
• Carboxymethylcellulose Sodium (analogs & derivatives, therapeutic use)
• Disease Progression
• Disease-Free Survival
• Female
• Glioma (pathology, therapy)
• Humans
• Interferon Inducers (therapeutic use)
• Magnetic Resonance Imaging (methods)
• Male
• Middle Aged
• Neoplasm Recurrence, Local (pathology, therapy)
• Poly I-C (therapeutic use)
• Polylysine (analogs & derivatives, therapeutic use)
• Treatment Outcome