Actively Recruiting
Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma
Led by Neonc Technologies, Inc. · Updated on 2026-03-02
49
Participants Needed
12
Research Sites
460 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy Study in Recurrent or Progressive Grade III or IV IDH1 Mutated Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Radiographically confirmed progression or recurrence of primary or secondary Grade IV glioma, including infratentorial and subcortical gliomas confirmed by biopsy
- Radiographically confirmed progression or recurrence of primary or secondary Grade III astrocytoma
- Stable or decreasing steroid dose for at least five days before informed consent
- Failed previous radiation or combined temozolomide and radiation treatment
- If progression occurs within 90 days of conformal radiation, progression must be outside radiation field or proven by biopsy/resection
- Age 18 years or older
- ECOG performance status 0-2 or Karnofsky Performance Status (KPS) 60 or higher (KPS for Phase 1 only)
- Expected survival of at least three months
- Baseline MRI with gadolinium within 14 days before first study drug administration
- Willingness to provide blood samples for pharmacokinetic studies
- If seizures are present, controlled on stable anti-epileptic dose for 14 days before informed consent
- Adequate organ and marrow function: absolute neutrophil count ≥ 1,500/mcL; platelets ≥ 100,000/mcL; total bilirubin normal; AST/ALT ≤ 2.5 times institutional upper limit; creatinine normal
- Agreement to use adequate contraception for females of child-bearing potential and males from 30 days before until 90 days after therapy
- Negative serum pregnancy test within 7 days before starting study drug for females of child-bearing potential
- Ability and willingness to provide written informed consent
- For Phase 2a: confirmed IDH1 mutation by rtPCR or immunohistochemistry unless continuing from Phase 1
You will not qualify if you...
- Tumor size larger than 30 mm in length x width on baseline MRI
- Multi-focal tumor on baseline MRI
- Completed chemo-radiation within 90 days before first study drug administration unless new enhancement is outside radiation field or biopsy-proven recurrence
- Surgery within seven days before informed consent
- Any anti-cancer therapy or treatment within 28 days before first study drug administration
- Not recovered from adverse events related to chemotherapy, immunotherapy, or radiation given more than 28 days before study drug start
- Prior treatment with bevacizumab, chemotherapy wafer implant (Gliadel®), or FDA-approved anti-cancer therapies except temozolomide
- More than one recurrence or progression of tumor
- Received investigational agents within 28 days before first study drug administration
- Prior perillyl alcohol treatment intravenously or intranasally
- History of allergic reactions to perillyl alcohol
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, arrhythmias, or psychiatric/social issues limiting compliance
- Pregnant or nursing women
- New diagnosis or treatment of cancer other than malignant glioma within five years except certain skin cancers
- Leptomeningeal involvement of tumor
AI-Screening
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Trial Site Locations
Total: 12 locations
1
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
2
Saint John Cancer Institute
Santa Monica, California, United States, 90404
Actively Recruiting
3
Georgia Cancer Center (Augusta University)
Augusta, Georgia, United States, 30912
Actively Recruiting
4
Ochsner Health
New Orleans, Louisiana, United States, 70121
Actively Recruiting
5
Atlantic Health (Overlook Medical Center)
Summit, New Jersey, United States, 07901
Actively Recruiting
6
Northwell Health
New York, New York, United States, 10016
Actively Recruiting
7
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
8
Cleveland Clinic
Cleveland, Ohio, United States, 44333
Actively Recruiting
9
Baylor Scott & White Health
Dallas, Texas, United States, 75061
Actively Recruiting
10
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
11
University of Washington Medical Center
Seattle, Washington, United States, 98105
Not Yet Recruiting
12
University of Wisconsin Hospital and Clinic
Madison, Wisconsin, United States, 53792
Not Yet Recruiting
Research Team
C
Christopher Beardmore
CONTACT
C
Chloe Richmond
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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