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Study of 4-Demethyl-4-cholesteryloxycarbonylpenclome (DM-CHOC-PEN) in Patients With Brain Tumors

NCT02038218 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2020-09-16

Study results available
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Summary

DM-CHOC-PEN is a polychlorinated pyridine cholesteryl carbonate that has demonstrated antineoplastic activities in patients with advanced cancers - melanoma, lung, breast and glioblastoma multiforme (GBM) involving the CNS during a Phase I study. These findings support the preclinical responses seen in mice bearing intracerebrally implanted human breast and GBM tumor xenografts. Toxicity was acceptable - hyperbilirubinemia (in patients with liver disease and/or liver metastasis). No hematological, renal, cardiovascular, behavioral or cognitive impairment/neurotoxicities were noted during the Phase I human trial or in previous pre-clinical studies.

The drug is available for use as a soy bean oil/egg yolk lecithin/glycerin water emulsion; the latter continues to be chemically and biologically stable and safe.

Patients with advanced lung, breast and melanoma cancers spread to the CNS and primary CNS malignancies will be eligible for enrollment and treatment, providing the required blood and other eligibility requirements are met. The trial will be 2-tiered - patients with liver involvement vs. non-liver involvement will be treated with different doses of the drug.

The trial is open and patients are currently being enrolled and treated with the protocol.

Conditions

  • Primary Brain Tumors
  • Metastatic Malignant Neoplasm to Brain

Interventions

DRUG

4-Demethyl-4-cholestryloxycarbonylpenclomedine

This will be an open-label, uncontrolled two-arm, multi-center study in patients with CNS involvement from melanoma, breast, lung cancers or primary malignancies of the CNS. Patients can be previously treated with radiation and systemic therapies and are eligible if they also have other sites of cancer involvement. Two Cohorts of patients will be treated every 21 days with a single infusion of DM-CHOC-PEN as an out-patient: Cohort 1: Patients with liver involvement or history of disease will be treated at a dose of 85.8 mg/m2 and; Cohort 2: Patients without liver involvement or history of liver disease, will be treated at a dose of 98.7 mg/m2. Patients in both cohorts will discontinue dosing with DM-CHOC-PEN when there are any unacceptable toxicities, progression of cancer or patient compliance.

Sponsors & Collaborators

  • Tulane University

    collaborator OTHER

  • Icahn School of Medicine at Mount Sinai

    collaborator OTHER

  • Detroit Clinical Research Center

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Ochsner Health System

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • DEKK-TEC, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-05-31
Completion
2020-08-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02038218 on ClinicalTrials.gov