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)

Department of Neurological Surgery, University of California San Francisco, San Francisco, CA 94143-0350, USA.
Journal of Neuro-Oncology (Impact Factor: 3.07). 10/2008; 91(2):175-82. DOI: 10.1007/s11060-008-9693-3
Source: PubMed


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).
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.
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.
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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Available from: Michael Prados, Feb 03, 2014
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    • "Twenty-two patients with recurrent malignant glioma (13 of whom had GBM) were treated with intranodal injections of αDC1 loaded with synthetic peptides for EphA2, IL13Rα2, YKL-40, and gp100 HLA-A2 restricted epitopes in this phase I/II study. Poly-ICLC, which has been used in previous clinical trials to treat patients with GBM [63, 64], was administered intramuscularly as an adjuvant in accordance with data demonstrating its ability to boost postvaccination immune response and to promote T cell infiltration into the tumor [34, 65]. "
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