NCT01654497

Dexanabinol in Patients With Brain Cancer

A Phase I, Sequential Cohort, Open-Label, Dose-escalation Study of the Safety and CNS Pharmacokinetics of Dexanabinol in Patients With Brain Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Santosh Kesari, M.D., Ph.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Brain Cancer

Interventions

Type	Name	Description
DRUG	Dexanabinol	Dexanabinol: intravenous infusion over 3 hours, weekly (i.e., Day 1, 8, 15 and 22 of a 28-day cycle) Nine dosing cohorts are planned, with the option to enroll additional cohorts based on safety and PK data. Dose Level 1: 2 mg/kg Dose Level 2: 4 mg/kg Dose Level 3: 8 mg/kg Dose Level 4: 16 mg/kg Dose Level 5: 24 mg/kg Dose Level 6: 28 mg/kg Dose Level 7: 36 mg/kg Dose Level 8: 40 mg/kg Dose Level 9: 44 mg/kg

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-09-01
• Completion: 2017-07-01
• First posted: 2012-07-31
• Last updated: 2019-11-14

Locations

1 site across 1 country: United States