Intravenous Iron in Combination With Standard of Care Immunotherapy in Melanoma

Indiana University

Status and phase: Withdrawn; Phase 2

Conditions: Melanoma; Anemia, Iron Deficiency

Treatments: Drug: Iron dextran 1000 mg IV

Study type: Interventional

Funder types: Other

Identifiers

NCT06508827

CTO-IUSCCC-0854

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Iron dextran 1000 mg IV

Experimental group

Description:

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

Treatment:

Drug: Iron dextran 1000 mg IV