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Phase III randomized trial of CED of IL13-PE38QQR vs Gliadel wafers for recurrent glioblastoma.

Publication ,  Journal Article
Kunwar, S; Chang, S; Westphal, M; Vogelbaum, M; Sampson, J; Barnett, G; Shaffrey, M; Ram, Z; Piepmeier, J; Prados, M; Croteau, D; Pedain, C ...
Published in: Neuro Oncol
August 2010

Convection-enhanced delivery (CED) of cintredekin besudotox (CB) was compared with Gliadel wafers (GW) in adult patients with glioblastoma multiforme (GBM) at first recurrence. Patients were randomized 2:1 to receive CB or GW. CB (0.5 microg/mL; total flow rate 0.75 mL/h) was administered over 96 hours via 2-4 intraparenchymal catheters placed after tumor resection. GW (3.85%/7.7 mg carmustine per wafer; maximum 8 wafers) were placed immediately after tumor resection. The primary endpoint was overall survival from the time of randomization. Prestated interim analyses were built into the study design. Secondary and tertiary endpoints were safety and health-related quality-of-life assessments. From March 2004 to December 2005, 296 patients were enrolled at 52 centers. Demographic and baseline characteristics were balanced between the 2 treatment arms. Median survival was 36.4 weeks (9.1 months) for CB and 35.3 weeks (8.8 months) for GW (P = .476). For the efficacy evaluable population, the median survival was 45.3 weeks (11.3 months) for CB and 39.8 weeks (10 months) for GW (P = .310). The adverse-events profile was similar in both arms, except that pulmonary embolism was higher in the CB arm (8% vs 1%, P = .014). This is the first randomized phase III evaluation of an agent administered via CED and the first with an active comparator in GBM patients. There was no survival difference between CB administered via CED and GW. Drug distribution was not assessed and may be crucial for evaluating future CED-based therapeutics.

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Published In

Neuro Oncol

DOI

EISSN

1523-5866

Publication Date

August 2010

Volume

12

Issue

8

Start / End Page

871 / 881

Location

England

Related Subject Headings

  • Young Adult
  • Recombinant Fusion Proteins
  • Polyesters
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Male
  • Magnetic Resonance Imaging
  • Kaplan-Meier Estimate
  • Interleukin-13
 

Citation

APA
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Kunwar, S., Chang, S., Westphal, M., Vogelbaum, M., Sampson, J., Barnett, G., … PRECISE Study Group. (2010). Phase III randomized trial of CED of IL13-PE38QQR vs Gliadel wafers for recurrent glioblastoma. Neuro Oncol, 12(8), 871–881. https://doi.org/10.1093/neuonc/nop054
Kunwar, Sandeep, Susan Chang, Manfred Westphal, Michael Vogelbaum, John Sampson, Gene Barnett, Mark Shaffrey, et al. “Phase III randomized trial of CED of IL13-PE38QQR vs Gliadel wafers for recurrent glioblastoma.Neuro Oncol 12, no. 8 (August 2010): 871–81. https://doi.org/10.1093/neuonc/nop054.
Kunwar S, Chang S, Westphal M, Vogelbaum M, Sampson J, Barnett G, et al. Phase III randomized trial of CED of IL13-PE38QQR vs Gliadel wafers for recurrent glioblastoma. Neuro Oncol. 2010 Aug;12(8):871–81.
Kunwar, Sandeep, et al. “Phase III randomized trial of CED of IL13-PE38QQR vs Gliadel wafers for recurrent glioblastoma.Neuro Oncol, vol. 12, no. 8, Aug. 2010, pp. 871–81. Pubmed, doi:10.1093/neuonc/nop054.
Kunwar S, Chang S, Westphal M, Vogelbaum M, Sampson J, Barnett G, Shaffrey M, Ram Z, Piepmeier J, Prados M, Croteau D, Pedain C, Leland P, Husain SR, Joshi BH, Puri RK, PRECISE Study Group. Phase III randomized trial of CED of IL13-PE38QQR vs Gliadel wafers for recurrent glioblastoma. Neuro Oncol. 2010 Aug;12(8):871–881.
Journal cover image

Published In

Neuro Oncol

DOI

EISSN

1523-5866

Publication Date

August 2010

Volume

12

Issue

8

Start / End Page

871 / 881

Location

England

Related Subject Headings

  • Young Adult
  • Recombinant Fusion Proteins
  • Polyesters
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Male
  • Magnetic Resonance Imaging
  • Kaplan-Meier Estimate
  • Interleukin-13