Intravenous Iron in Combination With Standard of Care Immunotherapy in Melanoma
Iron With Standard of Care Immunotherapy in Melanoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Recruiting
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center
-
Contact:
- Mateusz Opyrchal, MD
-
Contact:
- Anne Younger, RN
- Phone Number: (317) 274-0951
- Email: anefoste@iu.edu
-
Contact:
- Mateusz Opyrchal, MD, PhD
- Phone Number: (317) 278-8845
- Email: mopyrch@iu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥ 18 years old adults at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Biopsy confirmed melanoma
- Eligible for standard of care treatment
- Plan to undergo immunotherapy in neoadjuvant or metastatic setting
- ECOG performance status 0-2
- Anemia defined as hemoglobin < 13 g/dl in addition to ferritin < 100 ng/ml and/or transferrin saturation < 30%
Exclusion Criteria:
- History of anaphylactic reaction to intravenous iron or any proposed standard of care treatments
- Diagnosis of hemoglobinopathies
- Therapeutic Iron supplementation in the past 3 months (oral iron as part of MVI allowed)
- Diagnosis of hemochromatosis
- 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).
- Pregnant or lactating female adults
- Active infections which in research teams' opinion increases risk for toxicities
- Any condition that in the opinion of PI may interfere with patient being able to complete the required procedures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Iron dextran 1000 mg IV
Iron dextran 1000 mg IV will be administered once, about 7 days prior to standard of care treatment.
|
Iron dextran 1000 mg IV will be administered once, about 7 days prior to standard of care treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Erythroid progenitor cells (EPCs) detection in patient's blood
Time Frame: Baseline, 1 week post iron infusion, 21 days post iron infusion
|
Whether the erythroid progenitor cells (EPCs) can be detected at baseline in patient's blood in 3 out of 5 evaluable patients
|
Baseline, 1 week post iron infusion, 21 days post iron infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Iron dose tolerance
Time Frame: baseline
|
At least 50% of patients consented successfully receive >50% of planned iron infusion
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mateusz Oprychal, MD, PhD, Indiana University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Metabolic Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Skin Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Anemia
- Nevi and Melanomas
- Skin Neoplasms
- Iron Metabolism Disorders
- Anemia, Hypochromic
- Iron Deficiencies
- Melanoma
- Anemia, Iron-Deficiency
- Anticoagulants
- Hematinics
- Plasma Substitutes
- Blood Substitutes
- Dextrans
- Iron-Dextran Complex
Other Study ID Numbers
- CTO-IUSCCC-0854
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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