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Intravenous Iron for Melanoma

Phase 2
Recruiting
Led By Mateusz Oprychal, MD, PhD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status 0-2
≥ 18 years old adults at the time of informed consent
Must not have
Diagnosis of hemoglobinopathies
Therapeutic Iron supplementation in the past 3 months (oral iron as part of MVI allowed)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 week post iron infusion, 21 days post iron infusion
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to investigate whether administering iron before chemotherapy can improve the effectiveness of immunotherapy for melanoma by targeting cells that make treating melanoma difficult.

Who is the study for?
This trial is for melanoma patients with iron deficiency or anemia. Participants must not have received prior chemotherapy for their condition and should be eligible for standard immunotherapy treatment.
What is being tested?
The study tests if a single dose of intravenous Iron dextran (1000 mg) before standard immunotherapy can make melanoma more treatable by affecting certain cells.
What are the potential side effects?
Iron dextran may cause muscle cramps, nausea, temporary changes in taste, flushing, headache, dizziness, or joint pain. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to get out of my bed or chair and move around.
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I am 18 years old or older.
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My melanoma cannot be removed by surgery or has spread.
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I have anemia with low hemoglobin, ferritin, or transferrin saturation levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with a blood disorder affecting hemoglobin.
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I have not taken iron supplements in the last 3 months, except as part of a multivitamin.
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I have been diagnosed with hemochromatosis.
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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Erythroid progenitor cells (EPCs) detection in patient's blood
Secondary study objectives
Iron dose tolerance

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Iron dextran 1000 mg IVExperimental Treatment1 Intervention
Iron dextran 1000 mg IV will be administered once, about 7 days prior to standard of care treatment.

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,037 Previous Clinical Trials
1,218,968 Total Patients Enrolled
Mateusz OpyrchalLead Sponsor
Mateusz Oprychal, MD, PhDPrincipal InvestigatorIndiana University
~3 spots leftby Jun 2026
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