Health TrialsbyHealthPanel

NEO100 and High-Grade Meningioma

ConditionResidual, Progressive or Recurrent Grade II or III Meningioma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorNeonc Technologies, Inc.

About this trial

This multi-site, Phase 2 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 residual high-grade meningioma following resection surgery, radiographically-confirmed progression of high-grade meningioma or recurrent high-grade meningioma. There will be up to 30 patients enrolled in this study to have 29 evaluable patients. NEO100 will be self-administered four times daily on a 28-day treatment cycle until disease progression, death or patient withdraw from study for any reason, whichever occurs first.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have histologically confirmed WHO Grade II or III meningioma that is residual, progressive or recurrent following at least minimally safe resection and radiation therapy. Metastatic meningiomas are allowed.

Residual disease is defined as residual measurable disease (without a requirement for progression). Residual measurable disease is defined by bidimensionally measurable lesions with clearly defined margins by MRI scan(s) with a minimum diameter of 10mm in both dimensions.

Progressive disease is defined as an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area). The change must occur between scans separated by no more than 24 months.

Recurrent disease is defined as new evidence of measurable disease following complete resection (10mm in both dimensions).

Disqualifiers

Patients who have had chemotherapy, targeted small molecule therapy or study therapy within 14 days (or 5 half-lives, whichever is shorter) of study treatment.

Patient has completed chemo-radiation within the last 84 days prior to the first administration of study drug, unless new contrast enhancement is outside of radiation field, or there is tissue proven recurrence or progression.

Patient has had surgery within seven days prior to the date of informed consent.

Patient has had cytotoxic chemotherapy within 4 weeks (or 5 half-lives, whichever is shorter), nitrosoureas/alkylating agents within 6 weeks or biologic therapies.

Trial design

Design model

Single group

Treatments tested in this trial

  • NEO100

    Drug

    NEO100 is a purified form of perillyl alcohol.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Patients with high-grade meningiomaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression free survival as six months (PFS6).

Progression free survival

Time frame
6 months

Secondary outcomes

1

Objective Tumor response to NEO100 as determined by RANO criteria

Time frame
6 months
2

Overall survival

Time frame
12 months
3

Perillic acid measurement

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Neonc Technologies, Inc.

Lead sponsor

Source ClinicalTrials.gov
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