Pilot Trial Iron With Standard of Care Immunotherapy in Melanoma

CTO-IUSCCC-0854

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.

2024-09-01

2026-06-01

2027-06-01

Not yet recruiting

Early phase I

5

Inclusion Criteria: 1. ≥ 18 years old adults at the time of informed consent 2. Ability to provide written informed consent and HIPAA authorization 3. Unresectable or metastatic Melanoma 4. Eligible for standard of care treatment 5. ECOG performance status 0-2 6. 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5, 'type': 'ESTIMATED'}}

2024-07-18