Disulfiram + Chemotherapy for Pancreatic Cancer

Recruiting at 27 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Mayo Clinic

Must not be taking: Phenytoin, others

Disqualifiers: Brain metastases, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4-5 weeks

16 Participants Needed

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.

Research Team

Aminah Jatoi, M.D.

Principal Investigator

Mayo Clinic in Rochester

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

Your bilirubin levels are not more than twice the normal limit.

The level of a specific liver enzyme called AST is not more than 3 times the upper limit of normal. This test should be done within 7 days before joining the study.

My blood clotting time is within the normal range required for a biopsy.

Exclusion Criteria

You cannot stop drinking alcohol during the study.

Pregnant women

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive gemcitabine hydrochloride IV and disulfiram orally for 28 to 35 days

4-5 weeks

3 visits (in-person) for IV administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

1 visit (in-person), followed by every 6 months for 3 years

Treatment Details

Interventions

• Disulfiram
• Gemcitabine Hydrochloride

Trial Overview 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.

Participant Groups

Group I: Cohort II (chemotherapy and disulfiram) Experimental Treatment 3 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 Treatment 3 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:

• Alcohol dependence

Approved in European Union as Antabuse for:

• Alcohol dependence

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+