Iron With Standard of Care Immunotherapy in Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 5
- 主要终点
- Erythroid progenitor cells (EPCs) detection in patient's blood
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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%
排除标准
- •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.
研究组 & 干预措施
Iron dextran 1000 mg IV
Iron dextran 1000 mg IV will be administered once, about 7 days prior to standard of care treatment.
干预措施: Iron dextran 1000 mg IV (Drug)
结局指标
主要结局
Erythroid progenitor cells (EPCs) detection in patient's blood
时间窗: 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
次要结局
- Iron dose tolerance(baseline)
研究者
Mateusz Opyrchal
Associate Professor of Medicine
Indiana University School of Medicine