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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
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
1,044 Previous Clinical Trials
1,316,864 Total Patients Enrolled
2 Trials studying Melanoma
144 Patients Enrolled for Melanoma
Mateusz OpyrchalLead Sponsor
Mateusz Oprychal, MD, PhDPrincipal InvestigatorIndiana University