Trial Outcomes & Findings for Disulfiram and Copper Gluconate With Temozolomide in Unmethylated Glioblastoma Multiforme (NCT NCT03363659)

NCT ID: NCT03363659

Last Updated: 2024-10-03

Results Overview

To determine 6 month PFS of patients with unmethylated glioblastoma treated with DSF-Cu in combination with concurrent radiation and temozolomide. This was assessed by the number of participants who did not have disease progression and were alive at 6 months.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-10-03

Participant Flow

First subject enrollment 28th March 2018. Subjects screened at neuro-oncology MDCC (Multi-disciplinary cancer clinic) and enrolled at neuro-oncology clinic. Study closed 13th January 2022.

Participant milestones

Measure	Open Label Open-Label, Single Arm Study to Evaluate the Safety, Tolerability, and Efficacy of Disulfiram and Copper Gluconate When Added to Standard Temozolomide Treatment in Patients with Newly Diagnosed Resected Unmethylated Glioblastoma Multiforme
Overall Study STARTED	15
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Open Label Open-Label, Single Arm Study to Evaluate the Safety, Tolerability, and Efficacy of Disulfiram and Copper Gluconate When Added to Standard Temozolomide Treatment in Patients with Newly Diagnosed Resected Unmethylated Glioblastoma Multiforme
Overall Study Adverse Event	1
Overall Study Screen fail	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

15 subjects consented, Age data was not collected for 2 participants - 1 subject was a screen fail and 1 subject withdrew before any planned intervention.

Baseline characteristics by cohort

Measure	Open Label n=15 Participants Open-Label, Single Arm Study to Evaluate the Safety, Tolerability, and Efficacy of Disulfiram and Copper Gluconate When Added to Standard Temozolomide Treatment in Patients with Newly Diagnosed Resected Unmethylated Glioblastoma Multiforme. DSF will be given at 125 mg (half of a 250 mg capsule) two times daily with meals. Cu gluconate will be taken with each dose of DSF at a dose of 2 mg (one capsule/tablet). The DSF total daily dose will be 250 mg per day, as lower dose may be associated with a higher MGMT inhibitory effect.
Age, Categorical <=18 years	0 Participants n=13 Participants • 15 subjects consented, Age data was not collected for 2 participants - 1 subject was a screen fail and 1 subject withdrew before any planned intervention.
Age, Categorical Between 18 and 65 years	12 Participants n=13 Participants • 15 subjects consented, Age data was not collected for 2 participants - 1 subject was a screen fail and 1 subject withdrew before any planned intervention.
Age, Categorical >=65 years	1 Participants n=13 Participants • 15 subjects consented, Age data was not collected for 2 participants - 1 subject was a screen fail and 1 subject withdrew before any planned intervention.
Sex: Female, Male Female	3 Participants n=15 Participants
Sex: Female, Male Male	12 Participants n=15 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants
Race (NIH/OMB) Asian	0 Participants n=15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants
Race (NIH/OMB) Black or African American	1 Participants n=15 Participants
Race (NIH/OMB) White	14 Participants n=15 Participants
Race (NIH/OMB) More than one race	0 Participants n=15 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants
Region of Enrollment United States	15 Participants n=15 Participants

PRIMARY outcome

Timeframe: 6 months

To determine 6 month PFS of patients with unmethylated glioblastoma treated with DSF-Cu in combination with concurrent radiation and temozolomide. This was assessed by the number of participants who did not have disease progression and were alive at 6 months.

Outcome measures

Measure	Open Label n=12 Participants Open-Label, Single Arm Study to Evaluate the Safety, Tolerability, and Efficacy of Disulfiram and Copper Gluconate When Added to Standard Temozolomide Treatment in Patients with Newly Diagnosed Resected Unmethylated Glioblastoma Multiforme
6 Months Progression Free Survival (PFS)	1 Participants

PRIMARY outcome

Timeframe: 1 and 2 years

Population: 2 participants are not included here because 1 was a screen fail and 1 withdrew before starting treatment.

Overall Survival will be assessed as a number of participants alive at 1 and 2 years.

Outcome measures

Measure	Open Label n=13 Participants Open-Label, Single Arm Study to Evaluate the Safety, Tolerability, and Efficacy of Disulfiram and Copper Gluconate When Added to Standard Temozolomide Treatment in Patients with Newly Diagnosed Resected Unmethylated Glioblastoma Multiforme
Overall Survival 1 Year	9 Participants
Overall Survival 2 Years	2 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Disease progression or required dose modification from all participants took them all off the study. No data was collected.

Edmonton Symptom Assessment System - Revised (ESAS-r) questionnaire

Outcome measures

Outcome data not reported

Adverse Events

Open Label

Serious events: 1 serious events

Other events: 0 other events

Deaths: 11 deaths

Serious adverse events

Measure	Open Label n=13 participants at risk Open-Label, Single Arm Study to Evaluate the Safety, Tolerability, and Efficacy of Disulfiram and Copper Gluconate When Added to Standard Temozolomide Treatment in Patients with Newly Diagnosed Resected Unmethylated Glioblastoma Multiforme
Hepatobiliary disorders Hepatic Failure	7.7% 1/13 • Number of events 1 • Reportable adverse events will be tracked for 30 days after the last dose of DSF-Cu. Survival for participants was followed for up to 2 years. 13 participants started the treatment and the only ones assessed for adverse events. All participants were included in all cause mortality.

Other adverse events

Adverse event data not reported

Additional Information

Manager of Oncology research

Advocate Aurora Health

Phone: 414 778 4345

Email: karen.cheek@aah.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place