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).
OBJECTIVE
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
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.
Butowski
Nicholas
N
Department of Neurological Surgery, University of California San Francisco, San Francisco, CA 94143-0350, USA. butowski@neurosurg.ucsf.edu
Chang
Susan M
SM
Junck
Larry
L
DeAngelis
Lisa M
LM
Abrey
Lauren
L
Fink
Karen
K
Cloughesy
Tim
T
Lamborn
Kathleen R
KR
Salazar
Andres M
AM
Prados
Michael D
MD
D000328:Adult; D000368:Aged; D002266:Carboxymethylcellulose Sodium / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D005909:Glioblastoma / Q000628:therapy*; D006801:Humans; D007369:Interferon Inducers / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011070:Poly I-C / Q000627:therapeutic use*; D011107:Polylysine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011878:Radiotherapy / Q000379:methods*; D015173:Supratentorial Neoplasms / Q000628:therapy*
D007369:Interferon Inducers; D011107:Polylysine; C019531:poly ICLC; D002266:Carboxymethylcellulose Sodium; D011070:Poly I-C
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