OncoMatch/Clinical Trials/NCT02704858
Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma
Is NCT02704858 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Perillyl alcohol for glioblastoma multiforme.
Treatment: Perillyl alcohol — This multi-site, Phase 1/2a clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO100 (perillyl alcohol) for the treatment of patients with radiographically-confirmed progression of Grade IV glioma or recurrent primary or secondary Grade IV glioma. The study will have two phases, Phase 1 and Phase 2a. Phase 1 is a standard cohort dose escalation 3+3 design used to determine the maximum tolerated dose for Phase 2a. There will be up to 24 patients enrolled in Phase 1. There will be 25 patients enrolled in Phase 2a. For both phases of the study, NEO100 will be self-administered four times daily for a 28-day treatment cycles until disease progression, death or patient withdraw from study for any reason, whichever occurs first. Version 10 of the protocol changed the inclusion criteria for Phase 2a to limit inclusion to those patients with progressive or recurrent primary or secondary Grade IV gliomas expressing IDH1 mutations. Prior to the protocol amendment, 4 patients were enrolled who were IDH1 wild-type. Therefore, an additional 28 patients will be recruited for a total of 32 patients enrolled into Phase 2a of this study to have 35 evaluable cases. Version 12 of the protocol expanded the inclusion criteria for Phase 2a to include those patients with progressive or recurrent Grade III Astrocytoma expressing IDH1 mutations. Review of the literature specific to these patients found the same expected time to progression and death. As a result, the number of patients to enroll remains 32 to have 35 evaluable cases.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 mutation
Disease stage
Required: Stage GRADE III, GRADE IV (WHO)
Grade: IIIIV (WHO)
Grade III or IV glioma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: radiation therapy
Patient must have failed previous radiation treatment or combined treatment with temozolomide and radiation
Cannot have received: bevacizumab (bevacizumab)
prior treatment with bevacizumab
Cannot have received: chemotherapy wafer implant (Gliadel)
prior treatment with a chemotherapy wafer implant (Gliadel®)
Cannot have received: FDA-approved anti-cancer therapy
Exception: except temozolomide
prior treatment with any other FDA-approved anti-cancer therapy or treatment except temozolomide
Cannot have received: perillyl alcohol (perillyl alcohol)
prior treatment with perillyl alcohol, administered either intravenously or intranasally
Cannot have received: investigational agent
received any other investigational agents within 28 days prior to the first administration of study drug
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/mcL; Platelets ≥ 100,000/mcL
Kidney function
Creatinine within normal institutional limits
Liver function
Total bilirubin within normal institutional limits; AST (SGOT)/ALT (SPGT) ≤ 2.5 × institutional upper limit of normal
Absolute neutrophil count ≥ 1,500/mcL; Platelets ≥ 100,000/mcL; Total bilirubin within normal institutional limits; AST (SGOT)/ALT (SPGT) ≤ 2.5 × institutional upper limit of normal; Creatinine within normal institutional limits
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Southern California · Los Angeles, California
- Saint John Cancer Institute · Santa Monica, California
- Georgia Cancer Center (Augusta University) · Augusta, Georgia
- Ochsner Health · New Orleans, Louisiana
- Atlantic Health (Overlook Medical Center) · Summit, New Jersey
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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