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

5 Participants Needed

Trial Summary

What is the purpose of this trial?

Anemia is a common complication among cancer patients and is negatively associated with overall prognosis and therapeutic outcomes. The purpose of this study is to see if giving a dose of iron prior to any standard of care chemotherapy treatment will affect the cells that are believed to make treating melanoma harder, making melanoma more responsive to the standard of care immunotherapy.

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.

What data supports the effectiveness of the drug Iron dextran for treating melanoma?

While there is no direct evidence for Iron dextran's effectiveness in treating melanoma, intravenous iron formulations, including Iron dextran, have been shown to be effective in treating anemia in patients with other conditions, such as those undergoing dialysis or chemotherapy. These formulations help replenish iron stores quickly and are generally considered safe and effective for managing iron deficiency. ^{1 2 3 4 5}

How does intravenous iron differ from other treatments for melanoma?

Intravenous iron is unique for melanoma treatment as it involves administering iron directly into the bloodstream, which is different from typical melanoma treatments like surgery, chemotherapy, or immunotherapy. This approach is novel because it leverages the body's iron metabolism, which is not a standard method for treating melanoma. ^{2 3 5 6 7}

Research Team

Mateusz Oprychal, MD, PhD

Principal Investigator

Indiana University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Intravenous iron therapy: how far have we come? [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Sodium ferric gluconate complex in the treatment of iron deficiency for patients on dialysis. [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

The available intravenous iron formulations: History, efficacy, and toxicology. [2018]

4. New Zealand 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. Brazil pubmed.ncbi.nlm.nih.gov

Intravenous ferric carboxymaltose for the treatment of iron deficiency anemia. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of intravenous iron sucrose versus low-molecular-weight iron dextran in chronic kidney disease. [2018]