Iron Dextran with Standard of Care Immunotherapy to Improve the Treatment of Melanoma Patients with Anemia

Status: withdrawn

This phase II trial studies whether giving iron dextran with standard of care immunotherapy helps to improve the treatment of melanoma patients with low red blood cells (anemia). Anemia is a common complication among cancer patients, and it can lead to an increase in the cells that are believed to make treating melanoma more difficult. Iron is an important mineral the body needs to make red blood cells. Iron dextran is a dietary supplement given intravenously (IV) as iron-replacement therapy. Immunotherapy may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. 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. This may make the melanoma more responsive to the immunotherapy. Giving iron dextran with standard of care immunotherapy may improve the treatment of melanoma patients with anemia.

Inclusion Criteria

≥ 18 years old adults at the time of informed consent
Ability to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Unresectable or metastatic melanoma
Eligible for standard of care treatment
Plan to undergo immunotherapy in neoadjuvant or metastatic setting
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Anemia defined as hemoglobin < 13 g/dl in addition to ferritin < 100 ng/ml and/or transferrin saturation < 30%

Exclusion Criteria

History of anaphylactic reaction to intravenous iron or any proposed standard of care treatments
Diagnosis of hemoglobinopathies
Therapeutic iron supplementation in the past 3 months (oral iron as part of multivitamin [MVI] allowed)
Diagnosis of hemochromatosis
Symptomatic brain metastases that require local treatment (brain metastasis which will be treated with systemic immunotherapy or treated metastasis with without need for steroids for symptomatic management are eligible)
Pregnant or lactating female adults
Active infections which in research teams’ opinion increases risk for toxicities
Any condition that in the opinion of principal investigator (PI) may interfere with patient being able to complete the required procedures

PRIMARY OBJECTIVE:

I. Ability to detect erythrocyte precursor cells (EPCs) in circulation.

SECONDARY OBJECTIVE:

I. Feasibility of patients to receive > 50% of iron infusion before standard of care treatment.

OUTLINE:

Patients receive iron dextran IV over 2-4 hours approximately 7 days prior to standard of care treatment. Patients with ferritin < 100 ng/mL or iron saturation < 30% may receive further treatment with iron dextran per treating physician discretion and discussion with the research team. Patients also undergo blood sample collection throughout the study and may optionally undergo tissue biopsy throughout the study.

After completion of study treatment, patients are followed up at days 7 and 21 and then per standard of care treatment for approximately 1 year.

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Iron Dextran with Standard of Care Immunotherapy to Improve the Treatment of Melanoma Patients with Anemia

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