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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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".

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed locally advanced or metastatic disease of any histology that will receive chest radiation

Scheduled to receive RT as part of definitive local consolidation therapy (LCT) (not palliative)

Induction systemic therapy allowed, but just not concurrently given (washout for at least 3 weeks before start of CDT and RT)

Age ≥18 years.

Disqualifiers

Uncontrolled intercurrent illness.

Known hypersensitivity to Disulfiram.

Contraindications to radiation therapy.

Inability to stay away from alcohol products during the use of Disulfiram.

Trial design

Design model

Single group

Treatments tested in this trial

  • Disulfiram 250 mg

    Drug

    Given orally once daily

  • Copper Gluconate 2 mg

    Drug

    Given orally three times daily

  • Radiation Therapy

    Drug

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Treatment with Disulfiram + Copper Gluconate + Concurrent LCTExperimental treatment 3 interventions

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: