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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years after completion of treatment (up to 138 weeks after starting treatment)

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 3

~1020

Temozolomide

2010

Completed Phase 3

~1930

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,674 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What ailments commonly necessitate a surgical procedure?

"Nitrosourea therapy is usually managed through surgical means. This form of intervention may even be beneficial in treating advanced directives, refractory neuroblastoma, and mycosis fungoides that has not responded to other forms of treatment."

Answered by AI

Are there any other investigations exploring the effectiveness of Surgery?

"Currently, there are a total of 216 active studies concerning Surgery with 25 trials in their final stage. A majority take place in Houston, Texas; however, 4797 sites across the country are investigating this medical procedure."

Answered by AI

Does this research study have any openings for participants?

"According to clinicaltrials.gov, this medical research is no longer actively recruiting. First posted on June 15th 2016 and last updated July 22nd 2022, the trial has concluded its participant search; however there are still 658 other trials that are currently in need of volunteers."

Answered by AI

Is this a pioneering research endeavor?

"Presently, there are 216 ongoing medical studies associated with Surgery taking place in 36 distinct nations and 944 cities. The earliest of these trials was conducted by Schering-Plough in 2002, completing its Phase 2 approval stage after recruiting 60 participants. Since then, 492 similar investigations have been launched."

Answered by AI

What is the capacity of this medical trial, in terms of enrollees?

"Enrollment for this medical trial has been closed. It was initially published on June 15th 2016, and the webpage's most recent update is dated July 22nd 2022. As of now, 442 trials concerning glioblastoma are still recruiting participants while 216 studies regarding Surgery are actively seeking volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Disulfiram/Copper With Concurrent Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma

2016. "Disulfiram/Copper With Concurrent Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02715609.

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