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

PHASE2CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

May 31, 2016

Study Completion Date

August 31, 2020

Conditions
Primary Brain TumorsMetastatic 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."

Trial Locations (3)

48336

Detroit Clinical Research Centers, Lansing

70112

Tulane University Medical Center, New Orleans

77030

The University of Texas Health Science Center, Houston

All Listed Sponsors
collaborator

Tulane University

OTHER

collaborator

Icahn School of Medicine at Mount Sinai

OTHER

collaborator

Detroit Clinical Research Center

OTHER

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Ochsner Health System

OTHER

collaborator

The University of Texas Health Science Center, Houston

OTHER

lead

DEKK-TEC, Inc.

INDUSTRY

NCT02038218 - Study of 4-Demethyl-4-cholesteryloxycarbonylpenclome (DM-CHOC-PEN) in Patients With Brain Tumors | Biotech Hunter | Biotech Hunter