Study of 4-Demethyl-4-cholesteryloxycarbonylpenclome (DM-CHOC-PEN) in Patients With Brain Tumors
Status:
Completed
Trial end date:
2020-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
DEKK-TEC, Inc.
Collaborators:
Detroit Clinical Research Center, Farmington Hills, Lansing and Owasso, MI Icahn School of Medicine at Mount Sinai National Cancer Institute (NCI) Ochsner Health System The University of Texas Health Science Center, Houston Tulane University Medical Center, New Orleans, LA