Dexanabinol in Patients With Brain Cancer

Status Completed

Clinical Trial Summary

The purpose of this study is to try to determine the maximum safe dose of dexanabinol that can be administered to people with brain cancer. Other purposes of this study are to:

- find out what effects (good and bad) dexanabinol has;

- see how much drug gets into the body by collecting blood and cerebrospinal fluid for use in pharmacokinetic (PK) studies;

- learn more about how dexanabinol might affect the growth of cancer cells;

- look at biomarkers (biochemical features that can be used to measure the progress of disease or the effects of a drug).

Clinical Trial Description

Protection from apoptosis is a key survival factor for cancer cells. Dexanabinol is under investigation as a novel anti-cancer therapy based on its tumoricidal activity observed in vitro and in vivo, presumably due to inhibitory activity against NFĸB, TNFα, COX-2 and additional putative targets suck as HAT, FAT and cyclin dependent kinases. Targeted induction of apoptosis in cancer cells versus normal cells provides an attractive strategy for the treatment of brain cancer, a pernicious disease with debilitating neurological side effects and poor prognoses. A single intravenous dosing of dexanabinol has demonstrated safety in humans. Therefore, we are conducting a phase I dose escalation study to examine the safety of multiple dosing of dexanabinol and drug penetration into the brain, and to determine a suitable dose for moving into a phase II trial for efficacy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01654497
Study type	Interventional
Source	University of California, San Diego
Contact
Status	Completed
Phase	Phase 1
Start date	June 2012
Completion date	July 2017

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