Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508827
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Intravenous Iron in Combination With Standard of Care Immunotherapy in Melanoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Iron With Standard of Care Immunotherapy in Melanoma
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ngml 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 andor 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 differentiationmaturation 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
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 andor 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 differentiationmaturation 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None