A phase II clinical trial of poly-ICLC with radiation for adult patients with newly diagnosed supratentorial glioblastoma: a North American Brain Tumor Consortium (NABTC01-05).

Abstract

PURPOSE:

This phase II study was designed to determine the overall survival time of adults with supratentorial glioblastoma treated with the immune modulator, polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (poly-ICLC), in combination with and following radiation therapy (RT).

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.

• 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)

Chemical References

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

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)