Targeted Radiation Therapy for Ovarian Cancer: Intraperitoneal Treatment With 211-astatine-MX35 F(ab')2
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum observed concentration (Cmax) of Astatine 211
研究概览
简要总结
In this alpha-radioimmunotherapy study groups of 3 patients with recurring epithelial ovarian cancer treated by salvage chemo-therapy and being in complete or good partial remission will receive one intra peritoneal infusion of 211 astatine (211At)-MX35 F(ab')2 . Patients will receive a single dose of MX35 F(ab')2 radiolabeled with increasing activity concentration of 211At in 1.0 - 2 L Extraneal® solution starting at an activity concentration of 50 megabecquerel per litre (MBq/L).
详细描述
- Five days prior to therapy the patient is provided with a central intra venous line and an abdominal catheter will be introduced during laparoscopy. To investigate the access to the whole abdominal cavity and possible catheter leakage, a 99mTc-colloid, will be infused intra peritoneally (IP) within 1.0 L of a gluco-polymer (Extraneal®).
- At the day of treatment vital signs will be measured prior to and after the 30 min infusion and at least every second hour during the first 6 hours after infusion, daily for the remainder of the in-hospital stay and at a minimum at 2, 3, 4 and 8 weeks after the IP infusion. Blood samples will be obtained for pharmacokinetic analyses every hour after completion of the IP infusion for 8 hours, then every 6 hours, together with sampling from the i.p. catheter.
- SPECT imaging of the whole abdominal cavity and thorax including the thyroid may be performed following completion of the IP infusion and at approx 8 or 20hrs post infusion.
- Physical examination and electrocardiogram will be done prior to and 4 weeks after the IP infusion. Clinical biochemical and hematological parameters will be monitored weekly after treatment. Blood samples to evaluate immunogenicity as well as cancer antigen-125 (CA-125) will also be taken at 2 and 8 weeks after treatment.
- The first patient will be observed for at least 4 weeks with any observed toxicity is Grade 2 or less, before the additional patient is accrued at the dose level.
- Dosimetry safety criteria: Based upon published data on maximal tolerated absorbed dose (Gy) recalculated to equivalent dose (Sv) with the assumption that the relative biological effectiveness (RBE) = 5, a limit for organ doses is defined. If any organ would reach the defined limit the study will be stopped.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically confirmed ovarian or tubal or primary peritoneal adenocarcinoma.
- •Patients must have a recurrent intraperitoneal cancer and treated by a salvage chemotherapy to complete or good partial remission
- •The following laboratory and clinical results within 2 weeks prior to first study day:
- •Absolute neutrophil count (ANC) > 1.5 x 109/L Platelet count > 100 x 109/L Serum bilirubin < upper limit of normal(ULN) Aspartate aminotransaminase (ASAT) < 1.5 x ULN Serum aminotransferase (ALAT) < 1.5 x ULN Serum creatinine < 1.5 x upper limit of normal Thyreoglobulin baseline information Thyroid-stimulating hormone (TSH) baseline information T4 baseline information
- •Karnofsky performance status >
- •Must understand written and spoken Swedish
- •Before any trial-specific procedures or treatment can be performed, the patient must give written informed consent for participation in the trial.
排除标准
- •Active parenchymal disease (distant metastasis) (i.e. stage IV International Federation of Gynecology and Obstetrics (FIGO) classification.
- •Presence of diagnosed extra abdominal metastasis
- •Clinically significant heart disease.
- •Electrocardiographic demonstrating clinically significant arrhythmias.
- •Other serious illnesses, e.g. serious infections requiring antibiotics, coagulation disorders.
- •Chronic inflammatory bowel disease.
- •Chemotherapy, biologic therapy, or immunotherapy within 4 weeks prior
- •Advanced abdominal adherences.
研究组 & 干预措施
Intraperitoneal Radioimmunotherapy boost
Four groups of 3 patients with recurring ovarian cancer treated by salvage chemo-therapy and being in complete or good partial remission will receive one IP dose of 211astatine-MX35 F(ab'2). Starting at 50 MBq/L. Dose escalation 100 Mbq/L, 200 MBq/L and finally 300 MBq/L.
干预措施: 211-astatine MX35 F(ab')2 (Combination Product)
结局指标
主要结局
Maximum observed concentration (Cmax) of Astatine 211
时间窗: Sampled from +1 hour to +48 hrs post infusion.
Decay corrected activity concentration in serum, intraperitoneal fluid and urine.
Toxicity: hematology, liver, kidney, thyroid function
时间窗: From procedure start (implantation of catheter) to 8 weeks after infusion
As defined by NCI Common Toxicity Criteria v2.0
Area under the curve (AUC) of astatine 211 from time of dosing to 48 hrs after dosing
时间窗: Sampled from +1 hour to +48 hrs post infusion.
Decay corrected activity concentration in serum, intraperitoneal fluid and urine, including actual imaging quantification on gamma-Camera scintigraphy.
次要结局
未报告次要终点