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Spots Global Cancer Trial Database for Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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