PHASE IB STUDY TO EVALUATE SAFETY AND TOLERANCE OF REPETITIVE DAILY

RSR13是一种人工合成的血红蛋白变构修饰剂。它减少了 血红蛋白的氧亲和力和增加氧负荷 微血管系统将氧气扩散梯度增加到 纸巾。通过增加组织氧合，RSR13可能减少肿瘤 低氧和增强放射治疗的细胞毒性作用用于 治疗实体瘤癌症患者。为了测试安全性，耐受性， 和最大耐受量的RSR13，我们进行了一项非 对以下患者的随机、开放标签、多中心安全性研究 接受了为期六周的常规头颅放射治疗 多形性胶质母细胞瘤。参加这项研究的患者有 经组织学证实的幕上IV级星形细胞瘤 (多形性胶质母细胞瘤)。RSR13的剂量为100 mg/kg。 浓度20毫克/毫升，连续给药超过60分钟 通过中心静脉通路装置输液。RSR13管理开始 在放射治疗的第一天，并被给予这样的结束 输液在放射治疗开始前30分钟内进行。 心理治疗。两个剂量频率组，A组和B组，9名患者 每组，均使用。A组给予100 mg/kg RSR13 每隔一天进行一次放射治疗，B组患者接受 每日放射治疗100 mg/kg RSR13。

RSR13 is a synthetic allosteric modifier of hemoglobin. It decreases the oxygen affinity of hemoglobin and augments oxygen unloading in the microvasculature which increases the oxygen diffusion gradient to the tissues. By increasing tissue oxygenation, RSR13 may reduce tumor hypoxia and enhance the cytotoxic effects of radiation therapy used to treat cancer patients with solid tumors. To test the safety, tolerance, and maximally tolerated repetitive dose of RSR13, we conducted a non- randomized, open-label, multi-center safety study in patients who received a conventional six-week course of cranial radiation therapy for glioblastoma multiforme. Patients enrolled in this study had a histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme). The dose of RSR13 was 100 mg/kg at a concentration of 20 mg/mL, administered over 60 minutes by continuous infusion via a central venous access device. RSR13 administration began on the first day of radiation therapy and was given so that the end of the infusion occured within 30 minutes prior to the start of radiation therapy. Two dose frequency groups, Groups A and B, with nine patients per group, were used. Patients in Group A received 100 mg/kg RSR13 every other day of radiation therapy, and patients in Group B received 100 mg/kg RSR13 every day of radiation therapy.