Disulfiram/Copper + Radiation + Temozolomide for Glioblastoma

Recruiting in Palo Alto (17 mi)

Overseen byJiayi Huang, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Washington University School of Medicine

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

The proposed phase I/II study of disulfiram (DSF) for patients with presumed glioblastoma multiforme (GBM) based on magnetic resonance imaging (MRI) or biopsy, including administration before surgery and during adjuvant chemoradiotherapy. Patients will be treated with 3 days of preoperative DSF/copper (Cu) prior to their surgery (or biopsy), which will be followed by collection of tumor samples during surgery for analysis of drug uptake. After the surgery, patients will receive standard radiation therapy (RT) and temozolomide (TMZ) with the addition of concurrent DSF/Cu.

Research Team

Jiayi Huang, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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.

Inclusion Criteria

Willing to remain abstinent from consuming alcohol while on DSF

I am willing to wait a week for my surgery to start DSF and Cu treatment.

I am willing to use birth control.

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Exclusion Criteria

Enrolled on another clinical trial testing a novel therapy or drug

History of allergic reaction to DSF or Cu

I haven't taken any medications that are not allowed with DSF + Cu in the last 7 days.

See 6 more

Treatment Details

Interventions

Disulfiram (Alcohol Dehydrogenase Inhibitor)
Radiation (Radiation Therapy)
Surgery (Other)
Temozolomide (Chemotherapy Agent)

Trial OverviewThe 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.

Participant Groups

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.