It Is Time to Include Patients With Brain Tumors in Phase I Trials in Oncology
Year: 2011
Type: editorial
Abstract: Traditionally,themajorityofphaseIstudiesofnovelagentsin oncology have excluded patients with primary brain tumors. Although phase I studies are designed to determine optimal dosing, efficacy data are increasingly used to look for a signal in particular tumors. Excluding patients with primary brain tumors from phase I studies results in a significant handicap in the identification of drugs that may be particularly active in these tumor types. In this era of targeted therapies, we suggest that the reasons for excluding these patients are largely obsolete. It is time to reconsider this practice and include patients with brain tumors in phase I trials in oncology. Several reasons are given for the exclusion of patients with brain tumors from phase I trials. First, patients with brain tumors were historically treated with cytochrome P450 enzyme-inducing antiepileptic drugs (EIAEDs), such as phenytoin and carbamazepine, which potentially accelerated hepatic metabolism of the agent under study. Asaresult,aseparatephaseIstudywasoftenrequiredforpatientswith
Source: Journal of Clinical Oncology
Authors: Patrick Y. Wen, David Schiff, Timothy F. Cloughesy, David A. Reardon, Tracy T. Batchelor, Bruce A. Chabner, Keith Flaherty, John F. de Groot, Mark R. Gilbert, Evanthia Galanis, Susan M. Chang, Gary K. Schwartz, David Peereboom, Minesh P. Mehta, W.K. Alfred Yung, Stuart A. Grossman, Michael D. Prados, Lisa M. DeAngelis
Institutions: Brigham and Women's Hospital, Center for Neuro-Oncology, Dana-Farber Cancer Institute, Dana-Farber Brigham Cancer Center, University of Virginia, University of California, Los Angeles, Duke Medical Center, Massachusetts General Hospital, The University of Texas MD Anderson Cancer Center, Mayo Clinic, University of California, San Francisco, Memorial Sloan Kettering Cancer Center, Cleveland Clinic, Northwestern University, Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center
Language: English
Subfield: Genetics
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funder: National Cancer Institute
OpenAlex ID: W2162579704