Spots Global Cancer Trial Database for Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors
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Trial Identification
Brief Title: Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors
Official Title: A Phase I/II Study of the Combination of Indoximod and Temozolomide for Adult Patients With Temozolomide-Refractory Primary Malignant Brain Tumors
Study ID: NCT02052648
Study Description
Brief Summary: In this study, investigators will conduct a phase I/II trial in recurrent (temozolomide resistant) glioma patients. The overall goal of this study is to provide a foundation for future studies with indoximod tested in newly diagnosed glioblastoma patients with radiation and temozolomide, or in combination with vaccine therapies.
Detailed Description: The aim of this study is to identify the safety profile and the recommended dose for phase 2 study of the combination of indoximod (portion 1, phase 1b study). Investigators will then evaluate the tolerability and the preliminary activity in patients with recurrent GBM in three different situations: * Combination of indoximod and temozolomide (bevacizumab-naive patients) * Combination of indoximod and temozolomide in patients currently receiving or having received and failed bevacizumab. * Combination of indoximod and temozolomide with stereotactic radiation. Ancillary studies will be conducted to assess the correlation between intra-tumoral IDO expression or serum biomarkers (immune monitoring) and treatment efficacy. If the current study shows an acceptable safety profile and suggests preliminary evidence of activity, this will provide the justification for subsequent randomized phase 2 studies in refractory glioblastoma multiforme (GBM).
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Eden Medical Center, Castro Valley, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
UC Irvine Chao Family Comprehensive Cancer Center, Orange, California, United States
Moffitt Cancer Center, Tampa, Florida, United States
University Cancer and Blood Center, Athens, Georgia, United States
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
Augusta University, Augusta, Georgia, United States
University of Chicago, Chicago, Illinois, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
University of Kentucy, Lexington, Kentucky, United States
John Nasseff Neuroscience Institute, Minneapolis, Minnesota, United States
University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, United States
Wake Forest Baptist Health Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Penn State Hershey Medical Center, Hershey, Pennsylvania, United States
Texas Oncology, Austin, Texas, United States
Huntsman Cancer Center, Salt Lake City, Utah, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Contact Details
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