A North American brain tumor consortium phase II study of poly-ICLC for adult patients with recurrent anaplastic gliomas.
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.
Department of Neurological Surgery, University of California, San Francisco, San Francisco, CA 94143-0350, USA. butowski@neurosurg.ucsf.edu
Nicholas
N
Butowski
Kathleen R
KR
Lamborn
Bee L
BL
Lee
Michael D
MD
Prados
Timothy
T
Cloughesy
Lisa M
LM
DeAngelis
Lauren
L
Abrey
Karen
K
Fink
Frank
F
Lieberman
Minesh
M
Mehta
H
H
Ian Robins
Larry
L
Junck
Andres M
AM
Salazar
Susan M
SM
Chang
D000328:Adult; D000368:Aged; D001932:Brain Neoplasms / Q000473:pathology / Q000628:therapy*; D002266:Carboxymethylcellulose Sodium / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D005910:Glioma / Q000473:pathology / Q000628:therapy*; D006801:Humans; D007369:Interferon Inducers / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000473:pathology / Q000628:therapy*; D011070:Poly I-C / Q000627:therapeutic use*; D011107:Polylysine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
D007369:Interferon Inducers; D011107:Polylysine; C019531:poly ICLC; D002266:Carboxymethylcellulose Sodium; D011070:Poly I-C