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Disulfiram and Chemotherapy in Treating Patients With Refractory Solid Tumors or Metastatic Pancreatic Cancer

Refractory Malignant Solid Neoplasm Clinical Trial

Official title:
Expansion Cohort Study of Disulfiram and Chemotherapy in Pancreas Cancer Patients

Clinical Trial Summary

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.

Clinical Trial Description

PRIMARY OBJECTIVE: I. To determine the maximally tolerated dose (MTD) of the combination of disulfiram and gemcitabine (gemcitabine hydrochloride) in unresectable solid tumor cancer patients (Cohort 1). SECONDARY OBJECTIVES: I. To describe the adverse event profile associated with this combination of disulfiram and chemotherapy (Cohort 2). II. To describe changes in muscle area at the L3 level from baseline to 28 to 60 days from the baseline computed tomography (CT) scan in patients treated with disulfiram/chemotherapy and with placebo/chemotherapy (Cohort 2). III. To describe changes in fist-grip strength from baseline to 28 to 35 days of treatment with disulfiram/gemcitabine and with placebo/chemotherapy (Cohort 2). IV. To describe overall survival of pancreas cancer patients who disulfiram/chemotherapy or placebo/chemotherapy (Cohort 2). V. To estimate the response rate per Response Evaluation Criteria in Solid Tumors (RECIST) criteria around 1 month post-treatment in patients who receive disulfiram/chemotherapy and placebo/chemotherapy (Cohort 2). CORRELATIVE OBJECTIVE: I. To assess the effect of disulfiram and chemotherapy on the ubiquitin proteasome and autophagy pathways within muscle, as assessed by means of muscle biopsies performed at baseline and after 28 to 35 days of treatment (Cohort 2) (this is for Mayo only patients and can be waived upon permission from the principal investigator [PI]). OUTLINE: This is a phase I, dose-escalation study of disulfiram. COHORT I: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1, 8, and 15 and disulfiram orally (PO) on days 1-28 or days 1-35. COHORT II: Patients receive chemotherapy at the discretion of the treating oncologist and disulfiram PO on days 1-28 or days 1-35. After completion of study treatment, patients are followed up at 30 days, and then every 6 months for 3 years. ;

Study Design

Related Conditions & MeSH terms

  • Metastatic Pancreatic Adenocarcinoma
  • Pancreatic Neoplasms
  • Refractory Malignant Solid Neoplasm
  • Stage IV Pancreatic Cancer AJCC v8
Clinical Trial Details
NCT number NCT02671890
Study type Interventional
Source Mayo Clinic
Contact
Status Active, not recruiting
Phase Phase 1
Start date February 25, 2016
Completion date May 5, 2025
View Details
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