Intravenous Iron in Combination With Standard of Care Immunotherapy in Melanoma

Indiana University

Overview

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.

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 g/dl, ferritin levels below 100 ng/ml, and transferrin saturations of less than 30%. Cancer-associated anemia remains an underestimated and inadequately treated chronic condition that adversely affects the quality of life and overall prognosis in cancer patients. The correction of anemia in cancer patients would be a clinically applicable strategy to prevent and/or mitigate the expansion of tumor promoting erythroid progenitor cells (EPCs). Iron is an essential functional component of erythrocyte hemoglobin and is a crucial regulator of erythropoiesis. Strategies to therapeutically target the immunosuppressive machinery have emerged as a promising approach for cancer treatment. By promoting EPCs differentiation/maturation in anemic melanoma patients, immunosuppression could be mitigated and the therapeutic activity of immune checkpoint inhibitors enhanced. A dose of intravenous iron will be given one week prior to standard of care chemotherapy and antibodies CD71 and CD235a will be used to detect EPCs in circulation and tumor microenvironment.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Anemia, Iron Deficiency Melanoma

Interventions

Iron dextran 1000 mg IVDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. ≥ 18 years old adults at the time of informed consent 2. Ability to provide written informed consent and HIPAA authorization 3. Biopsy confirmed melanoma 4. Eligible for standard of care treatment 5. Plan to undergo immunotherapy in neoadjuvant or metastatic setting 6. ECOG performance status 0-2 7. Anemia defined as hemoglobin \< 13 g/dl in addition to ferritin \< 100 ng/ml and/or transferrin saturation \< 30% Exclusion Criteria: 1. History of anaphylactic reaction to intravenous iron or any proposed standard of care treatments 2. Diagnosis of hemoglobinopathies 3. Therapeutic Iron supplementation in the past 3 months (oral iron as part of MVI allowed) 4. Diagnosis of hemochromatosis 5. 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). 6. Pregnant or lactating female adults 7. Active infections which in research teams' opinion increases risk for toxicities 8. Any condition that in the opinion of PI may interfere with patient being able to complete the required procedures.

Outcomes

Primary Outcomes

Erythroid progenitor cells (EPCs) detection in patient's blood

Whether the erythroid progenitor cells (EPCs) can be detected at baseline in patient's blood in 3 out of 5 evaluable patients

Time frame: Baseline, 1 week post iron infusion, 21 days post iron infusion

Secondary Outcomes

Iron dose tolerance

At least 50% of patients consented successfully receive \>50% of planned iron infusion

Time frame: baseline

Data from ClinicalTrials.gov

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