Clinical trial · Interventional

Intravenous Iron in Combination With Standard of Care Immunotherapy in Melanoma

Iron With Standard of Care Immunotherapy in Melanoma

NCT06508827CI-TRIAL-00091945withdrawnPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Difficulty recruiting participants

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Anemia, Iron Deficiency	—	UNRESOLVED	—
Melanoma	Melanoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Iron dextran 1000 mg IV	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Iron dextran 1000 mg IV
description
Iron dextran 1000 mg IV will be administered once, about 7 days prior to standard of care treatment.
interventionNames
1. Drug: Iron dextran 1000 mg IV

Primary outcomes (1)

measure
Erythroid progenitor cells (EPCs) detection in patient's blood
timeFrame
Baseline, 1 week post iron infusion, 21 days post iron infusion
description
Whether the erythroid progenitor cells (EPCs) can be detected at baseline in patient's blood in 3 out of 5 evaluable patients

Secondary outcomes (1)

measure
Iron dose tolerance
timeFrame
baseline

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. ≥ 18 years old adults at the time of informed consent
2. Ability to provide written informed consent and HIPAA authorization
3. Biopsy confirmed melanoma
4. Eligible for standard of care treatment
5. Plan to undergo immunotherapy in neoadjuvant or metastatic setting
6. ECOG performance status 0-2
7. 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.

References

Publications (0)

Data not yet available

No reference posted for this study.