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Alcohol Dehydrogenase Inhibitor

Disulfiram/Copper + Radiation + Temozolomide for Glioblastoma

Phase 1 & 2
Waitlist Available
Led By Jiayi Huang, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age
Karnofsky performance status (KPS) of at least 60%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years after completion of treatment (up to 138 weeks after starting treatment)
Awards & highlights

Study Summary

This trial will test the effects of disulfiram on patients with brain tumors.

Who is the study for?
This trial is for adults with newly diagnosed glioblastoma who can undergo standard radiation and chemotherapy. They must have a certain level of physical function, be able to take oral medication, and women must use birth control. People taking specific medications or with severe diseases, pregnant or breastfeeding women, and those with a history of Wilson's disease are excluded.Check my eligibility
What is being tested?
The study tests Disulfiram/Copper combined with standard treatments (surgery, radiation therapy, Temozolomide) in patients with glioblastoma. It includes preoperative treatment before surgery and continued administration during subsequent chemoradiotherapy.See study design
What are the potential side effects?
Potential side effects may include reactions related to Disulfiram/Copper such as liver issues or neurological changes. Standard treatment side effects like nausea from chemo or skin irritation from radiation are also possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I need occasional assistance but am able to care for most of my personal needs.
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I am set to receive standard radiation therapy with TMZ.
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I have been diagnosed with Grade IV brain cancer.
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My brain tumor is confirmed to have specific genetic changes.
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I am willing to wait a week for my surgery to start DSF and Cu treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years after completion of treatment (up to 138 weeks after starting treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years after completion of treatment (up to 138 weeks after starting treatment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD) of the regimen (dose-escalation phase only)
Overall survival (dose-expansion phase only)
Secondary outcome measures
Active DSF metabolite concentration in plasma and tumor tissues (dose-expansion phase only)
Gene therapy
Intratumoral drug uptake of DSF and its metabolites in resected GBM tissue (dose-escalation phase only)
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: DSF, Cu, Surgery, RT, TMZ (dose expansion)Experimental Treatment5 Interventions
Surgery performed per routine clinical care. RT 4-6 weeks following surgery at 60 Gy in 30 daily fractions. TMZ from Day 1 of RT to the last day of RT at a daily oral dose for a maximum of 49 days as per standard clinical care. DSF QD and Cu TID during chemoradiotherapy as per preoperative dose 4-6 weeks after completion of chemoradiotherapy, adjuvant TMZ may be administered for 6 cycles. TMZ on Days 1-5 of every 28-day cycle. Daily DSF of 500mg will be continued with adjuvant TMZ for up to 6 cycles. If a patient develops recurrent tumor during follow-up and plans to undergo another resection, he/she may opt for an optional preoperative DSF study prior to salvage surgery.
Group II: DSF, Cu, Surgery, RT, TMZ (dose escalation)Experimental Treatment5 Interventions
DSF (dose level (DL) 1=125mg, DL 2=250mg, DL 3=375 mg, DL 4=500mg). DSF starts at DL 2 and escalated using the Time-to-Event Continual Reassessment Method 3 day lead-in of oral DSF once daily (QD) prior to surgery (optional) 2 mg Cu gluconate 3 times daily (TID) on days when DSF is given (optional pre-surgery) Surgery performed per routine clinical care. After surgery, evaluation to confirm the final pathological diagnosis as GBM (if not the patient will not continue with the 2nd part of the study). RT 4-6 weeks following surgery at 60 Gy in 30 daily fractions. TMZ from Day 1 of RT to the last day of RT at a daily oral dose for a maximum of 49 days as per standard clinical care. DSF QD and Cu TID during chemoradiotherapy as per preoperative dose 4-6 weeks after completion of chemoradiotherapy, adjuvant TMZ may be administered for 6 cycles. TMZ on Days 1-5 of every 28-day cycle. Daily DSF of 500mg will be continued with adjuvant TMZ for up to 6 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Disulfiram
2008
Completed Phase 4
~1300
Copper Gluconate
2008
Completed Phase 1
~30
Surgery
2000
Completed Phase 3
~2550
Radiation
2003
Completed Phase 2
~780
Temozolomide
2010
Completed Phase 3
~1930

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,944 Previous Clinical Trials
2,304,458 Total Patients Enrolled
17 Trials studying Glioblastoma
586 Patients Enrolled for Glioblastoma
Jiayi Huang, M.D.Principal InvestigatorWashington University School of Medicine
6 Previous Clinical Trials
179 Total Patients Enrolled
2 Trials studying Glioblastoma
39 Patients Enrolled for Glioblastoma

Media Library

Disulfiram (Alcohol Dehydrogenase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02715609 — Phase 1 & 2
Glioblastoma Research Study Groups: DSF, Cu, Surgery, RT, TMZ (dose escalation), DSF, Cu, Surgery, RT, TMZ (dose expansion)
Glioblastoma Clinical Trial 2023: Disulfiram Highlights & Side Effects. Trial Name: NCT02715609 — Phase 1 & 2
Disulfiram (Alcohol Dehydrogenase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02715609 — Phase 1 & 2
~1 spots leftby Sep 2024
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