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DM-CHOC-PEN for Brain Tumors in AYA Subjects

NCT03668847 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-11-08

No results posted yet for this study

Summary

4-Demethyl-4-cholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) is a polychlorinated pyridyl cholesterol carbonate that is lipophilic, electrically neural, crosses the blood brain barrier (BBB), ability to localize in intracranial tumor tissue, lacks neurotoxicity and not transported out of the brain via Pgp (p-glycoprotein). DM-CHOC-PEN has completed a Phase I Adolescent and Young Adult (AYA) trial in humans, some of which possessed primary and secondary tumors involving the brain. Complete remissions in both primary (astrocytoma, GBM) and metastatic lung cancers were reported.

This Phase II trial is closed for adolescent and young adults (AYA) subjects with advanced cancer - brain involvement is required.

Conditions

Interventions

DRUG

DM-CHOC-PEN

DM-CHOC-PEN administration by IV infusion

Sponsors & Collaborators

  • DEKK-TEC, Inc.

    lead INDUSTRY

Principal Investigators

  • Ali Baghian, MD · Tulane University Medical Center

  • Tallat Mahmmod, MD · Detroit Clinical Research Center

  • Marcus L Ware, MD · Ochsner Health System

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-08-31
Completion
2021-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03668847 on ClinicalTrials.gov