This study of DSF-Cu in combination with TMZ for recurrent GBM will evaluate the antitumor effect in patients who have recurrent GBM. Patients will take DSF-Cu daily during their routine standard of care with TMZ therapy for approximately 6 months. Patients will be evaluated for response every 8 weeks. Patients will be followed up 2 years after the last dose of DSF-Cu.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Disulfiram/copper gluconate is taken three times a day.
TMZ is given per standard of care
Beaumont Hospital
Royal Oak, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Lenox Hill Hospital
New York, New York, United States
Objective Response Rate
ORR will be defined as the percentage of patients with complete response (CR) or partial response (PR) according to the RANO criteria.
Time frame: 6 months
Progression Free Survival
Percentage of patients that are free from progressive disease per RANO criteria
Time frame: 6 months
Overall Survival
Percentage of patients that are alive
Time frame: 6 months and 12 months
Number of Participants With Serious Adverse Events
Number of Participants with Grade 3 and 4 serious adverse events
Time frame: 14 months
Median Progression Free Survival
Duration of progression free survival according to RANO criteria
Time frame: 12 months
Median Duration of Overall Survival
Duration of overall survival for patients that are alive
Time frame: 14 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Cincinnati
Cincinnati, Ohio, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States