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Clinical Trial Detail

Safety and Efficacy Study in Recurrent Grade IV Glioma

Complete title: An Open-Label, Phase 1/2a Dose Escalation Study of Safety and Efficacy of NEO100 in Recurrent Grade IV Glioma

Research Study Number 20160816
 
Principal Investigator Lynne Taylor, MD
 
Phase I/II

Research Study Description

NEO100-01 is a Phase 1/2A study of the monoterpene, perillyl alcohol (NEO100)in patients with recurrent glioblastoma. NEO100 is delivered four times a day by intranasal administration using a nebulizer and nasal mask for up to 6 months. Four escalating doses will be evaluated for tolerability, and the maximum tolerated dose will be extended in the 2A phase for a total of 25 patients. There is no concurrent control. This is the first nasal administration in the US, after prior oral studies with perillyl alcohol proved ineffective. Nasal administration of perillyl alcohol is on-going in Brazil

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "LOOK UP TRIAL AT NIH" link above. **

Other eligibility criteria may apply.

Research Study Number 20160816
 
Contact Seattle Cancer Care Alliance Intake Office
 
Telephone 800-804-8824 / 206-606-1024
 

Keywords: Glioma; Solid Tumors; Neoplasms, Germ Cell and Embryonal; Glioblastoma; Astrocytoma; Neuroectodermal Tumors; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Neuroepithelial

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