29
Participants
Start Date
September 30, 2013
Primary Completion Date
May 31, 2016
Study Completion Date
August 31, 2020
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."
Detroit Clinical Research Centers, Lansing
Tulane University Medical Center, New Orleans
The University of Texas Health Science Center, Houston
Collaborators (2)
Tulane University
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
Detroit Clinical Research Center
OTHER
National Cancer Institute (NCI)
NIH
Ochsner Health System
OTHER
The University of Texas Health Science Center, Houston
OTHER
DEKK-TEC, Inc.
INDUSTRY