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Trial Title:
Intravenous Iron in Combination With Standard of Care Immunotherapy in Melanoma
NCT ID:
NCT06508827
Condition:
Anemia, Iron Deficiency
Melanoma
Conditions: Official terms:
Melanoma
Anemia, Iron-Deficiency
Iron Deficiencies
Dextrans
Iron-Dextran Complex
Conditions: Keywords:
Erythroid Progenitor Cells
Iron
Anemia
Melanoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Iron dextran 1000 mg IV
Description:
Iron dextran 1000 mg IV will be administered once, about 7 days prior to standard of care
treatment.
Arm group label:
Iron dextran 1000 mg IV
Summary:
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.
Detailed description:
This is a pilot single arm, non-randomized study involving adult patients with melanoma
receiving standard of care treatment for non-resectable or metastatic disease with
ferritin levels below 30 ng/ml and transferrin saturations of less than 20%.
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.
Criteria for eligibility:
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. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anne Younger, RN
Phone:
317-274-0951
Email:
anefoste@iu.edu
Contact backup:
Last name:
Mateusz Opyrchal, MD, PhD
Phone:
(317) 278-8845
Email:
mopyrch@iu.edu
Investigator:
Last name:
Mateusz Opyrchal, MD
Email:
Principal Investigator
Start date:
December 2024
Completion date:
June 2026
Lead sponsor:
Agency:
Indiana University
Agency class:
Other
Source:
Indiana University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06508827
