Intravenous Iron in Combination With Standard of Care Immunotherapy in Melanoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06508827
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Indiana University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Mateusz Oprychal, MD, PhD
Principal Investigator Affiliation	Indiana University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Anemia, Iron Deficiency, Melanoma

Additional Details

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.

Arms & Interventions

Arms

Experimental: Iron dextran 1000 mg IV

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

Interventions

Drug: - Iron dextran 1000 mg IV

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Indianapolis, Indiana

Status

Recruiting

Address

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202

Site Contact

Anne Younger, RN

[email protected]

(317) 274-0951

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