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Not yet recruitingNCT07843537Updated Sep 28, 2026

MINTER Trial: Metal Intervention aNd ThErapy With Radiotherapy In Thoracic Cancer Using Copper Donor Therapy: A Phase 2, Open-Label Study

A Phase 2 interventional study of Disulfiram 250 mg and Copper Gluconate 2 mg in Thoracic Cancer, sponsored by M.D. Anderson Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study is being done to test whether adding two drugs-disulfiram and copper gluconate-to radiation therapy can help overcome this resistance and improve treatment outcomes. When disulfiram is combined with copper, it forms a substance that may increase stress within cancer cells and lead to a specific type of cancer cell death knowns as "cuproptosis".

Read the detailed description

Primary Objectives:

  • Evaluate the safety and feasibility of CDT (disulfiram + copper gluconate) during RT in patients undergoing radiotherapy within the thorax.
  • Evaluate the progression free survival (PFS) time.

Secondary Objectives:

  • Monitor all treatment-related adverse events from CDT during RT.
  • Assess local control (LC) at 6 months.

Exploratory Objectives:

  • Evaluate cuproptosis-related gene expression and biomarkers of copper metabolism in the baseline biopsy tissues and associate with treatment response. We aim to identify cuproptosis gene signatures (e.g., FDX1, LIAS, DLAT, PDHA1, MT1E, MT1X) as predictive biomarkers of therapeutic response.
  • Evaluate the potential for continued CDT during adjuvant immunotherapy
02

Conditions studied

  • Thoracic Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Histologically confirmed locally advanced or metastatic disease of any histology that will receive chest radiation
  2. Scheduled to receive RT as part of definitive local consolidation therapy (LCT) (not palliative)
  3. Induction systemic therapy allowed, but just not concurrently given (washout for at least 3 weeks before start of CDT and RT)
  4. Age ≥18 years.
  5. ECOG 0-2.
  6. Adequate organ and marrow function within 28 days prior to enrollment defined as:

    • Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L
    • Platelet count ≥100 × 10⁹/L
    • Hemoglobin ≥9 g/dL
    • Serum creatinine ≤1.5 × upper limit of normal (ULN) or creatinine clearance ≥50 mL/min
    • Total bilirubin ≤1.5 × ULN (≤3 × ULN for patients with known Gilbert's syndrome)
    • AST and ALT ≤2.5 × ULN (≤5 × ULN for patients with hepatic metastases)
  7. Ability to provide written informed consent.
  8. Prior thoracic radiation allowed as long as cumulative organ as risk constraints are met

Exclusion criteria

Exclusion Criteria:

  1. Uncontrolled intercurrent illness.
  2. Known hypersensitivity to Disulfiram.
  3. Contraindications to radiation therapy.
  4. Inability to stay away from alcohol products during the use of Disulfiram.
  5. Wilson's Disease (copper overload disorder)
  6. Hepatic dysfunction with AST/ALT/bilirubin levels that are outside 2.5 X normal range (≤2.5 × ULN)
  7. Hypersensitivity to copper-containing compounds
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Treatment with Disulfiram + Copper Gluconate + Concurrent LCT

    Drug: Disulfiram 250 mg · Drug: Copper Gluconate 2 mg · Drug: Radiation Therapy

Interventions

  • DrugDisulfiram 250 mg

    Given orally once daily

    Also known as: Antabuse

  • DrugCopper Gluconate 2 mg

    Given orally three times daily

  • DrugRadiation Therapy

    Delivered per institutional standards (radiotherapy alone in 10-15 fractions as local consolidation therapy).

05

What researchers measure

Primary outcomes

  1. Safety and Adverse Events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0

    Time frame: Through study completion; an average of 1 year

06

Study locations

1 site
  • UT MD Anderson
    Houston, Texas 77030, United States
    • Steven Lin, MD, PHD · Contact · shlin@mdanderson.org · 713-563-8490
    • Steven Lin, MD, PHD · Principal investigator
07

Registry details

Key details

Study ID
NCT07843537
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Sep 28, 2026
Start date
Mar 1, 2027 (estimated)
Primary completion
Mar 30, 2030 (estimated)
Completion
Mar 30, 2032 (estimated)
Last update
Sep 28, 2026

Study contacts

Steven Lin, MD, PHD
Contact
shlin@mdanderson.org
(713) 563-8490
Steven Lin, MD, PHD
principal investigator · UT MD Anderson

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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