NCT03054909已完成2 期
QUILT-2.021: Randomized Study of Single Course of Intraperitoneal (IP) ALT-803 Followed by Subcutaneous (SQ) Maintenance ALT-803 Versus Subcutaneous (SQ) Maintenance ALT-803 Only After 1st Line Chemotherapy for Advanced Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
This is a single center, randomized phase II study of an IL-15Rα-Fc super-agonist complex (ALT-803) given as maintenance therapy after the completion of 1st line IV/IP chemotherapy for the treatment of advanced ovarian, fallopian tube, and primary peritoneal cancer.
详细描述
In this study all patients receive four 8 week cycles of ALT-803 consisting of 4 weekly doses followed by a 4 week rest (no treatment). As it is not known how intraperitoneal (IP) administration (a route of drug administration frequently used for gynecologic cancers) of ALT-803 compares to subcutaneous (SQ) administration, both routes of administration will be tested. The primary objective of this trial is to select one method of delivery for further testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of FIGO stage III or grade IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma, has received at least 3 cycles of first line IV/IP cisplatin and paclitaxel chemotherapy and has stable disease or better - refer to Appendix II for FIGO staging system (Note: to be eligible for this study, the patient must receive a minimum of 3 cycles of IP therapy; however, patients may continue on IV only 1st line therapy for additional cycles as long as inclusion criteria 4.1.2 is met)
- •Able to begin study therapy within 3 months of final dose of first line chemotherapy
- •Functioning intraperitoneal catheter
- •≥ 18 years of age
- •GOG performance status ≤ 2 (Appendix II)
- •Adequate organ function within 14 days of enrollment defined as:
- •Hematology: hemoglobin ≥ 8 g/dl, absolute neutrophil count (ANC) ≥ 1500/ul, platelets ≥ 50 x 109/L
- •Creatinine: ≤ 2.0 mg/dL
- •Hepatic: SGOT and SGPT ≤ 3 x upper limit of institutional normal (ULN)
- •Ability to be off prednisone and other immunosuppressive drugs for at least 3 days prior to and while receiving ALT-803
- •Voluntary written consent prior to the performance of any research related procedures
排除标准
- •Received any investigational agent within the 14 days before the start of ALT-803
- •Class II or greater New York Heart Association Functional Classification criteria (Appendix II) or serious cardiac arrhythmias likely to increase the risk of cardiac complications of cytokine therapy (e.g. ventricular tachycardia, frequent ventricular ectopy, or supraventricular tachyarrhythmia requiring chronic therapy)
- •Marked baseline prolongation of QT/QTc interval (e.g. demonstration of a QTc interval greater than 500 milliseconds)
- •Uncontrolled bacterial, fungal or viral infections including HIV-1/2 or active hepatitis C/B - chronic asymptomatic viral hepatitis is allowed
- •Active autoimmune disease requiring systemic immunosuppressive therapy
- •History of severe asthma and currently on chronic systemic medications (mild asthma requiring inhaled steroids only is eligible)
- •Uncontrolled hypertension: defined as ≥2 readings over 160 mmHg systolic or 110 mmHg diastolic within month prior to enrollment despite optimal anti-hypertensive medication. Patients with high readings which improve to ≤160/110 after adjustment of medications will be eligible.
- •History of pulmonary disease or abnormal pulmonary function studies
- •History of narcolepsy or any neurological condition which may impair consciousness
研究组 & 干预措施
Arm 2: ALT-803 intraperitoneal and subcutaneous
Experimental
干预措施: ALT-803 Intraperitoneal (Biological)
Arm 1: ALT-803 subcutaneous only
Experimental
干预措施: ALT-803 Subcutaneous (Biological)
结局指标
主要结局
Progression Free Survival
时间窗: 6 months
Incidence of Progression Free Survival after first treatment of ALT-803.
次要结局
- ALT-803 Associated Toxicities(1 year)
- Overall Survival(2 year)
- Progression Free Survival(2 years)
- Incidence of Recorded Toxicity Grade 3 or Greater(1 year)
- Progression Free Survival(1 year)
- Overall Survival(1 year)
研究者
研究点 (1)
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