MedTrace Logo

DM-CHOC-PEN Plus Radiation for Brain Tumors

NCT03371004 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-11-04

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) (1). DM-CHOC-PEN has completed Phase I/II trials in humans with primary and secondary tumors involving the brain with success. Complete remissions in both primary astrocytoma and metastatic lung and leukemia malignancies.

This trial is open for adult subjects with advanced cancer - brain involvement is required.

Conditions

Interventions

DRUG

4-Demethyl-4-cholesteryloxycarbonylpenclomedine

IV administration as described

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • DEKK-TEC, Inc.

    lead INDUSTRY

Principal Investigators

  • Steven DiBiase, MD · Tulane University Medical Center

  • Lee Roy Morgan, MD, PhD · DEKK-TEC, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-05
Primary Completion
2022-10-01
Completion
2022-10-01
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 NCT03371004 on ClinicalTrials.gov