What side effects are associated with this type of intervention?

Common treatments for sarcoma, such as liposomal doxorubicin, are associated with side effects including reversible myelosuppression, mucositis, alopecia, nausea, vomiting, and both acute and chronic cardiotoxicity. The liposomal formulation of doxorubicin aims to reduce cardiotoxicity compared to its conventional form. Disulfiram, when combined with copper, is being studied for its potential to enhance chemotherapy efficacy, though specific side effects of this combination are less well-documented. General chemotherapy side effects also include fatigue, neutropenia, gastrointestinal disturbances, and skin reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for sarcoma, including traditional chemotherapeutic agents like doxorubicin, which is often used in its liposomal form to enhance delivery and reduce toxicity. While Disulfiram and Copper Gluconate are not standard treatments for sarcoma, liposomal doxorubicin is a well-established option. Other FDA-approved drugs for sarcoma include ifosfamide, methotrexate, and pazopanib, which target various pathways involved in cancer cell growth and survival. The combination of Disulfiram and Copper Gluconate with Liposomal Doxorubicin represents a novel approach, leveraging the unique properties of these agents to potentially improve outcomes in treatment-refractory sarcomas.

What other types of research exist?

Promising alternatives for sarcoma treatment include: 1) CuSO4 plus A23187 formulation with irinotecan, which has shown significant improvement in drug retention and therapeutic activity. 2) Caelyx (liposomal doxorubicin) which has demonstrated enhanced efficacy and reduced toxicity in metastatic prostate cancer and other settings. 3) Cyclophosphamide combined with CuDIPS or Tween 80, which has significantly reduced tumor incidence and improved survival rates in reticulum cell sarcoma models. These alternatives should be discussed with a healthcare provider to determine the best course of action based on individual patient needs and the latest clinical data.

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Copper Supplement

Disulfiram + Copper Gluconate + Liposomal Doxorubicin for Sarcoma

Phase 1

Recruiting

Led By Matteo Trucco, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have histologically confirmed relapsed or refractory sarcoma

Prior treatment toxicities must have stabilized or resolved to ≤ Grade 1 according to NCI CTCAE Version 5.0 except alopecia, neuropathy and hematologic criteria (must meet normal organ and marrow function criteria above)

Must not have

Has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy

Know condition preventing safe administration of copper such as a copper allergy or Wilson's Disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2 months

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial tests a new treatment combining a drug for alcoholism, a copper supplement, and a special chemotherapy for patients whose sarcomas came back or didn't respond to initial treatment. The goal is to make the chemotherapy work better by stopping the cancer from resisting it. Researchers are checking if this combination is safe and effective.

Who is the study for?

This trial is for patients with sarcomas that didn't get better after initial treatment. They must have a certain level of health, be able to swallow pills or take them with food, not drink alcohol, and use effective birth control if needed. People allergic to the drugs used or with serious illnesses that could affect safety or data integrity can't join.

What is being tested?

The study tests combining disulfiram (DSF) and copper gluconate (Cu) with liposomal doxorubicin in treating stubborn sarcomas. It aims to see if this mix is safe for those whose cancer has come back or resisted first-line treatments.

What are the potential side effects?

Possible side effects include reactions related to liver function changes, blood cell counts alterations, potential digestive issues from swallowing pills, and general discomforts like fatigue which are common in cancer therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My sarcoma has come back or didn't respond to treatment.

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My side effects from previous treatments are mild or gone, except for hair loss, nerve issues, or blood-related conditions.

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I, or my guardian if I'm under 18, can understand and agree to sign the consent form.

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I can swallow pills or take them with food if needed.

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I can do most of my daily activities by myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an ongoing serious infection that needs treatment.

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I do not have a copper allergy or Wilson's Disease.

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I am not part of another cancer drug study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of dose-limiting toxicities (DLT)

Number of participants able to take at least 80% of the drug doses during the first cycle of treatment

Number of participants who experienced drug-attributed grade 3+ Adverse events per CTCAE5.0

+2 more

Secondary study objectives

Median Event free survival

Median Overall Survival (OS)

Percent of participants with tumor response evaluated using RECIST v1.1

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1Treatment groups

Experimental Treatment

Group I: DSF/CuExperimental Treatment3 Interventions

A 3+3 dose escalation design will be used to determine the recommended phase 2 dose (RP2D) of DSF/Cu in combination with liposomal doxorubicin. There will be a 7 day "lead-in" week of Disulfiram (DSF)/Copper Gluconate (Cu). The disulfiram and the copper gluconate will be dosed once a day. Disulfiram in the morning and copper gluconate in the evening. Same total daily dose every 4 week (28 days) administration of liposomal doxorubicin (Doxil) 30mg/m2/dose IV Cycle length: 28 days Maximum 12 cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Copper gluconate

FDA approved

Disulfiram

FDA approved

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Disulfiram inhibits acetaldehyde dehydrogenase, leading to the accumulation of toxic metabolites that can induce cancer cell death. Copper Gluconate provides essential copper, which can enhance the cytotoxic effects of disulfiram. Liposomal Doxorubicin is a form of chemotherapy that uses liposomes to deliver doxorubicin more effectively to cancer cells, reducing side effects and improving efficacy. Ifosfamide, another common treatment, is an alkylating agent that damages DNA, leading to cell death. Pazopanib is a multikinase inhibitor that targets angiogenesis, reducing tumor blood supply. These mechanisms are crucial for sarcoma patients as they offer targeted approaches to disrupt cancer cell survival and proliferation, potentially improving outcomes and reducing adverse effects.

Phase III trial of two investigational schedules of ifosfamide compared with standard-dose doxorubicin in advanced or metastatic soft tissue sarcoma: a European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Study.