Intravenous Iron for Melanoma

Overseen By Anne Younger, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Indiana University

Must not be taking: Therapeutic iron

Disqualifiers: Hemoglobinopathies, Hemochromatosis, Brain metastases, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether administering a dose of iron before standard cancer treatment can make melanoma, a type of skin cancer, more responsive to therapy. Researchers aim to determine if this approach can improve treatment outcomes for patients with melanoma who also have anemia, a condition characterized by a lack of healthy red blood cells. The trial involves administering iron dextran (also known as CosmoFer or Infed) through an IV one week before starting regular cancer treatment. This trial may suit individuals with confirmed melanoma who plan to begin immunotherapy and have anemia. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking therapeutic iron supplements, you must have stopped them at least 3 months before joining the trial.

Is there any evidence suggesting that iron dextran is likely to be safe for humans?

Research has shown that iron dextran, used in this trial, has been studied in cancer patients with anemia (low red blood cell count). These studies found that intravenous iron, such as iron dextran, can safely raise hemoglobin levels (a protein in red blood cells) and reduce the need for blood transfusions, leading to fewer hospital visits for patients.

However, iron dextran carries some risks. Some studies consider it a possible carcinogen, meaning it might cause cancer. Despite this, it has been used in other treatments for anemia related to cancer.

This trial is in the early stages, focusing on safety. Past studies suggest that iron dextran is generally well-tolerated, but participants should be aware of the potential risks and discuss them with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for melanoma?

Most treatments for melanoma typically involve surgery, immunotherapy, targeted therapy, chemotherapy, or radiation. However, iron dextran is unique because it introduces a new approach by potentially enhancing the effectiveness of these standard treatments. Delivered intravenously, iron dextran could improve the body's response to melanoma by addressing iron deficiencies, which are sometimes associated with this condition. Researchers are excited about its potential to boost the overall impact of existing therapies, offering an innovative angle in melanoma treatment.

What evidence suggests that iron dextran might be an effective treatment for melanoma?

Research shows that iron dextran, which participants in this trial will receive, might improve anemia in cancer patients and potentially enhance melanoma treatment effectiveness. Anemia can hinder melanoma treatment, so addressing it might boost the efficacy of standard therapies. Although no direct evidence links iron dextran to treating melanoma itself, administering iron through an IV has shown promise in improving anemia. This improvement could lead to better overall results when combined with standard melanoma treatments. By addressing anemia, the body might respond more effectively to conventional cancer-fighting drugs. ^{1 2 3 4 6}

Who Is on the Research Team?

Mateusz Oprychal, MD, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for melanoma patients with iron deficiency or anemia. Participants must not have received prior chemotherapy for their condition and should be eligible for standard immunotherapy treatment.

Inclusion Criteria

I am eligible for standard treatment options.

I am able to get out of my bed or chair and move around.

Ability to provide written informed consent and HIPAA authorization

Exclusion Criteria

Active infections which in research teams' opinion increases risk for toxicities

Any condition that in the opinion of PI may interfere with patient being able to complete the required procedures

I have brain metastases not needing steroids for symptoms, treatable with immunotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Iron Administration

A dose of intravenous iron is administered to participants one week prior to standard of care chemotherapy

1 week

1 visit (in-person)

Treatment

Participants receive standard of care chemotherapy and immunotherapy

3 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Iron dextran

Trial Overview

The study tests if a single dose of intravenous Iron dextran (1000 mg) before standard immunotherapy can make melanoma more treatable by affecting certain cells.

How Is the Trial Designed?

Group I: Iron dextran 1000 mg IV Experimental Treatment 1 Intervention

Iron dextran 1000 mg IV will be administered once, about 7 days prior to standard of care treatment.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Mateusz Opyrchal

Lead Sponsor

Trials

1

Recruited

5+

Published Research Related to This Trial

A study comparing low-molecular-weight iron dextran (CosmoFer) and iron sucrose (Venofer) in 979 and 504 doses respectively showed that TDI CosmoFer is effective in improving iron levels in patients with chronic kidney disease (CKD) over 4-6 months.

TDI CosmoFer was found to be safe, with only three minor adverse events reported compared to one in the Venofer group, and no serious allergic reactions occurred in either treatment group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of intravenous iron sucrose versus low-molecular-weight iron dextran in chronic kidney disease. Sinha, S., Chiu, DY., Peebles, G., et al.[2018]

Sodium ferric gluconate complex in sucrose, recently approved for intravenous use in the U.S., is expected to have a better safety profile compared to the previously used iron dextran, which has been linked to severe adverse reactions and even deaths.

This review aims to evaluate existing literature on sodium ferric gluconate to develop a clinical strategy for its use as an adjunctive therapy in treating anemia in dialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium ferric gluconate complex in the treatment of iron deficiency for patients on dialysis. Fishbane, S., Wagner, J.[2019]

Intravenous (i.v.) iron supplementation is crucial for patients receiving epoetin therapy, as it ensures effective delivery of iron to the bone marrow, enhancing the response to treatment, despite requiring careful clinical supervision.

While there are concerns about potential long-term risks associated with i.v. iron, such as iron overload and increased risk of infections, evidence suggests that when monitored properly, the benefits of i.v. iron in optimizing epoetin therapy outweigh these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for iron supplementation: oral versus intravenous. Macdougall, IC.[2019]

Intravenous ferric carboxymaltose is a safer alternative to traditional intravenous iron preparations, as it does not contain dextran and has a very low risk of causing anaphylactic reactions, making it more suitable for treating iron deficiency anemia.

This treatment allows for the administration of large doses (up to 1000 mg in a single 15-minute infusion) without the need for a test dose, which can significantly improve the efficiency of iron replenishment in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous ferric carboxymaltose for the treatment of iron deficiency anemia. Friedrisch, JR., Cançado, RD.[2022]

Oral iron supplementation is effective and cost-efficient for treating iron deficiency anemia (IDA), but it often causes gastrointestinal side effects and requires a long treatment duration.

New intravenous iron preparations, developed in the last five years, offer improved safety profiles and faster iron replenishment, allowing for higher doses without the risk of anaphylactic reactions associated with older formulations like iron dextran.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous iron therapy: how far have we come? Cançado, RD., Muñoz, M.[2021]

Current intravenous iron formulations, including low molecular weight iron dextran, iron sucrose, and ferric gluconate, are considered safe and effective for treating anemia in patients undergoing chemotherapy or hemodialysis, with no major differences in efficacy or safety among them.

Administering a single total dose infusion of iron preparations is as effective and safe as multiple low doses, leading to fewer infusion reactions, reduced need for office visits, and greater convenience for both patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The available intravenous iron formulations: History, efficacy, and toxicology. Auerbach, M., Macdougall, I.[2018]

In a study of 30 cancer patients with gastrointestinal tumors undergoing chemotherapy, intravenous iron (ferric carboxymaltose) significantly improved hemoglobin levels and other iron status parameters over a treatment period of 12-14 weeks.

The treatment was well tolerated, with only one reported adverse event, indicating that ferric carboxymaltose is a safe and effective option for managing iron-deficiency anemia in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of intravenous iron in the treatment of anemia in patients with gastrointestinal tract tumors undergoing chemotherapy: a single-center, observational study. Lima, J., Gago, P., Rocha, M., et al.[2022]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06508827

Intravenous Iron in Combination With Standard of Care ...

This is a pilot single arm, non-randomized study involving adult patients with melanoma receiving standard of care treatment with hemoglobin levels less than 13 ...

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cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-08681

Iron Dextran with Standard of Care Immunotherapy to ...

Giving iron dextran with standard of care immunotherapy may improve a patient's anemia, which may reduce the cells that make treating melanoma more difficult.

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withpower.com/trial/phase-2-iron-deficiencies-8-2024-a0eef

Intravenous Iron for Melanoma · Info for Participants

While there is no direct evidence for Iron dextran's effectiveness in treating melanoma, intravenous iron formulations, including Iron dextran, have been shown ...

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ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK590779/

Iron Dextran Complex - 15th Report on Carcinogens - NCBI

Iron dextran complex is reasonably anticipated to be a human carcinogen based on sufficient evidence of carcinogenicity from studies in ...

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clinicaltrials.gov/study/NCT06508827?cond=%22Melanoma%22&intr=%22Dextrans%22&viewType=Table&rank=1

Intravenous Iron in Combination With Standard of Care ...

An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

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Intravenous Iron Therapy to Treat Anemia in Oncology

Overall, the studies reported that the use of IV iron increased hemoglobin concentration and decreased transfusion rates during different cancer treatment ...