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Clinical Trial Summary

Investigators are testing new experimental drug combinations such as the combination of vorinostat, vincristine, irinotecan, and temozolomide in the hopes of finding a drug that may be effective against tumors that have come back or that have not responded to standard therapy. The goals of this study are: - To find the highest safe dose of vorinostat that can be given together with vincristine, irinotecan, and temozolomide without causing severe side effects; - To learn what kind of side effects this four drug combination can cause; - To learn about the effects of vorinostat and the combination of vorinostat, vincristine, irinotecan, and temozolomide on specific molecules in tumor cells; - To determine whether the combination of vorinosat, vincristine, irinotecan, and temozolomide is a beneficial treatment.


Clinical Trial Description

This first cycle will be used to determine whether the patient can tolerate the chemotherapeutic backbone without developing a DLT. The baseline disease evaluation will be obtained following hematologic recovery from the first cycle of chemotherapy, after which combination therapy with vorinostat will be given in subsequent cycles (2-12) w/ modifications if needed. Vorinostat dose escalation in subsequent patient cohorts will occur based on DLT to determine a MTD. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04308330
Study type Interventional
Source New York Medical College
Contact Harshini Mahanti, BS
Phone 914-594-2143
Email harshini_mahanti@nymc.edu
Status Recruiting
Phase Phase 1
Start date March 17, 2017
Completion date December 31, 2024

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