Window of Opportunity Clinical Trials to Evaluate Novel Therapies for Brain Tumors

Visish M. Srinivasan, Chibawanye Ene, Brittany Parker Kerrigan, Frederick F. Lang

Research output: Contribution to journalReview articlepeer-review

6 Scopus citations

Abstract

Despite significant improvement in understanding of molecular underpinnings driving glioblastoma, there is minimal improvement in overall survival of patients. This poor outcome is caused in part by traditional designs of early phase clinical trials, which focus on clinical assessments of drug toxicity and response. Window of opportunity trials overcome this shortcoming by assessing drug-induced on-target molecular alterations in post-treatment human tumor specimens. This article provides an overview of window of opportunity trials, including novel designs for incorporating biologic end points into early stage trials in context of brain tumors, and examples of successfully executed window of opportunity trials for glioblastoma.

Original languageEnglish (US)
Pages (from-to)93-104
Number of pages12
JournalNeurosurgery clinics of North America
Volume32
Issue number1
DOIs
StatePublished - Jan 2021

Keywords

  • Biologic end points
  • Biomarkers
  • Brain tumors
  • Clinical trials
  • Immunotherapy
  • Molecular markers
  • Oncology
  • Window of opportunity

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

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