• DOI:10.1200/JCO.2008.16.7510
• Corpus ID: 25697247

Randomized phase II study of cilengitide, an integrin-targeting arginine-glycine-aspartic acid peptide, in recurrent glioblastoma multiforme.

@article{Reardon2008RandomizedPI,
  title={Randomized phase II study of cilengitide, an integrin-targeting arginine-glycine-aspartic acid peptide, in recurrent glioblastoma multiforme.},
  author={David A. Reardon and Karen L. Fink and Tom Mikkelsen and Timothy F. Cloughesy and Alison O'Neill and Scott R. Plotkin and Michael J. Glantz and Paula D. Ravin and Jeffrey J. Raizer and Keith M Rich and David Schiff and William R. Shapiro and Susan Burdette-Radoux and Edward J. Dropcho and Sabine M Wittemer and Johannes Nippgen and Martin Picard and Louis Burt Nabors},
  journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology},
  year={2008},
  volume={26 34},
  pages={
          5610-7
        }
}

• D. Reardon, K. Fink, +15 authors L. Nabors
• Published 1 December 2008
• Medicine, Biology
• Journal of clinical oncology : official journal of the American Society of Clinical Oncology

PURPOSE
Cilengitide, an inhibitor of alphavbeta3 and alphavbeta5 integrin receptors, demonstrated minimal toxicity and durable activity across a wide range of doses administered to adults with recurrent glioblastoma multiforme (GBM) in a prior phase I study. The current multicenter phase II study was conducted to evaluate the activity and safety of cilengitide in GBM patients at first recurrence.

PATIENTS AND METHODS
Eligible patients were randomly assigned to receive either 500 or 2,000 mg of cilengitide twice weekly on a continuous basis. Patients were assessed every 4 weeks. The primary end point was 6-month progression-free survival (PFS) rate. Secondary end points included PFS, overall survival (OS), and radiographic response, as well as quality-of-life and pharmacokinetic assessments.

RESULTS
Eighty-one patients were enrolled, including 41 on the 500-mg arm and 40 on the 2,000-mg arm. The safety profile of cilengitide was excellent, with no significant reproducible toxicities observed on either arm. Antitumor activity was observed in both treatment cohorts but trended more favorably among patients treated with 2,000 mg, including a 6-month PFS of 15% and a median OS of 9.9 months.

CONCLUSION
Cilengitide monotherapy is well tolerated and exhibits modest antitumor activity among recurrent GBM patients. Additional studies integrating cilengitide into combinatorial regimens for GBM are warranted.