Disulfiram + Chemotherapy for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+27 other locations

Overseen ByAminah Jatoi, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?This partially randomized phase I trial studies the side effects and best dose of disulfiram when given together with chemotherapy in treating patients with a solid tumor that does not respond to treatment (refractory) or pancreatic cancer that has spread to other places in the body (metastatic) and to compare whether disulfiram and chemotherapy may reduce tumor induced muscle loss. Weight loss occurs in pancreatic cancer patients and is common in a multitude of other cancers. Patients with metastatic cancer and weight loss sometimes are not able to receive treatment due to physical weakness or debility. Disulfiram is a potential inhibitor of muscle degradation and may reduce tumor induced muscle wasting. Disulfiram may also help chemotherapy work better by making tumor cells more sensitive to the drug. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving chemotherapy with or without disulfiram is a better treatment for refractory solid tumors or metastatic pancreatic cancer.

Eligibility Criteria

This trial is for adults with solid tumors that are untreatable by standard methods or metastatic pancreatic cancer. Participants must have acceptable blood counts, organ function, and be able to take oral medication. Women of childbearing potential must use effective contraception and not be pregnant or nursing. People can't join if they have curative treatment options available, uncontrolled illnesses, untreated brain metastases, certain neuropathy levels, or are using specific drugs like phenytoin.

Inclusion Criteria

I am able to care for myself and perform daily activities.

I can swallow pills or receive them through a G-tube.

I have an incurable solid tumor with no effective standard treatment options.

Exclusion Criteria

I have moderate to severe numbness or pain in my hands or feet.

There is a known cure for my condition.

I have brain metastases that have not been treated.

I am currently taking phenytoin.

I am currently breastfeeding.

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Participant Groups

The study is testing the combination of Disulfiram (a drug potentially preventing muscle wasting) with chemotherapy (Gemcitabine Hydrochloride) in patients whose cancers haven't responded to other treatments. The goal is to find the safest dose of Disulfiram and see if it enhances chemotherapy's effectiveness while reducing muscle loss associated with cancer.

2Treatment groups

Experimental Treatment

Group I: Cohort II (chemotherapy and disulfiram)Experimental Treatment3 Interventions

Patients receive chemotherapy at the discretion of the treating oncologist and disulfiram PO on days 1-28 or days 1-35.

Group II: Cohort I (gemcitabine hydrochloride and disulfiram)Experimental Treatment3 Interventions

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and disulfiram PO on days 1-28 or days 1-35.

Disulfiram is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Antabuse for: