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.
Butowski
Nicholas
N
Department of Neurological Surgery, University of California, San Francisco, San Francisco, CA 94143-0350, USA. butowski@neurosurg.ucsf.edu
Lamborn
Kathleen R
KR
Lee
Bee L
BL
Prados
Michael D
MD
Cloughesy
Timothy
T
DeAngelis
Lisa M
LM
Abrey
Lauren
L
Fink
Karen
K
Lieberman
Frank
F
Mehta
Minesh
M
Ian Robins
H
H
Junck
Larry
L
Salazar
Andres M
AM
Chang
Susan M
SM
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