RECRUITING

Intravenous Iron in Combination With Standard of Care Immunotherapy in Melanoma

Talk to us

Conditions

Anemia, Iron DeficiencyMelanomaErythroid Progenitor CellsIronAnemia

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Iron With Standard of Care Immunotherapy in Melanoma

Quick Facts

Study Start:2024-12
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06508827

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ≥ 18 years old adults at the time of informed consent
  2. 2. Ability to provide written informed consent and HIPAA authorization
  3. 3. Unresectable or metastatic Melanoma
  4. 4. Eligible for standard of care treatment
  5. 5. ECOG performance status 0-2
  6. 6. Anemia defined as hemoglobin \< 13 g/dl in addition to ferritin \< 100 ng/ml and/or transferrin saturation \< 30%
  1. 1. History of anaphylactic reaction to intravenous iron or any proposed standard of care treatments
  2. 2. Diagnosis of hemoglobinopathies
  3. 3. Therapeutic Iron supplementation in the past 3 months (oral iron as part of MVI allowed)
  4. 4. Diagnosis of hemochromatosis
  5. 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. 6. Pregnant or lactating female adults
  7. 7. Active infections which in research teams' opinion increases risk for toxicities
  8. 8. Any condition that in the opinion of PI may interfere with patient being able to complete the required procedures.

Contacts and Locations

Study Contact

Anne Younger, RN
CONTACT
(317) 274-0951
anefoste@iu.edu
Mateusz Opyrchal, MD, PhD
CONTACT
317-278-8845
mopyrch@indiana.edu

Principal Investigator

Mateusz Oprychal, MD, PhD
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Mateusz Oprychal, MD, PhD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-12
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Erythroid Progenitor Cells
  • Iron
  • Anemia
  • Melanoma

Additional Relevant MeSH Terms

  • Anemia, Iron Deficiency
  • Melanoma