EUCTR2019-003857-27-NL进行中（未招募）1 期
177Lu-PSMA Radioligand Therapy for advanced salivary gland cancer, a phase II pilot study. - LUPSA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Radboudumc
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients must have the ability to provide written informed consent.
- •- Patients must be = 18 years of age.
- •- Patients must have an ECOG performance status of 0 to 2.
- •- Patients must have histological, pathological, and/or cytological confirmation of either adenoid cystic carcinoma or salivary duct carcinoma.
- •- Patients must have incurable, local or regional recurrent or metastatic ACC or SDC.
- •- Patients with ACC can only participate in case of objective growth in the last three months or complaints due to the disease.
- •- Patients must have adequate organ function:
- •Sufficient bone marrow capacity as defined by: WBC count (white blood cell) =2.5x10^9/L, PLT (platelet) count =100x10^9/L, Hb =6 mmol/L, absolute neutrophil count (ANC) =1.5x10^9/L
- •Adequate liver function as defined by: Total bilirubin =1.5 x ULN. For patients known with Gilbert’s Syndrome = 3 x ULN is permitted. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3.0 × ULN OR =5.0 × ULN for patients with liver metastases.
- •Adequate kidney function as defined by: Serum creatinine =1.5 x ULN or creatinine clearance = 50 mL/min
- •- Patients must have measurable disease at baseline. Defined as = 1 lesion = 2 cm (long axis) that is present on baseline CT.
- •- Patients must have a positive 68Ga-PSMA PET/CT scan, defined by at least one lesion = 1.5 cm (long axis) with a ligand uptake above liver level.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •- Patients whom are pregnant or breast feeding.
- •- Patients with reproductive potential not implementing adequate contraceptives measures.
- •- Patients with known brain metastases or cranial epidural disease or intracardial metastases.
- •- Patients with concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other significant comorbid conditions that in the opinion of the investigator would impair study participation or cooperation.
- •- Patients with urinary tract obstruction or marked hydronephrosis
- •- Less than 4 weeks since last myelosuppressive therapy or other radionuclide therapy.
- •- Concomitant cancer treatments
研究者
相似试验
招募中
2 期
177Lu-PSMA Radioligand Therapy for advanced salivary gland cancer, a phase II pilot study.NL-OMON48525Radboud Universitair Medisch Centrum10
已完成
1 期
An early phase clinical trial evaluating the effectiveness of treatment of 177Lu-PSMA with idronoxil in men with castrate-resistant prostate cancer (LuPin Trial)ACTRN12618001073291St Vincent's Hospital Sydney56
招募中
1 期
[177Lu]Lu-PSMAI&T radioligand therapy (PSMA-RLT) in patients with prostate cancer and biochemical but not radiomorphologic local recurrence after primary therapy with curative intention: a future planned phase II studyProstate cancerEUCTR2022-003713-11-ATMedical University of Vienna20
进行中（未招募）
2 期
Lutetium-177-PSMA-617 in Oligo-metastatic Hormone Sensitive Prostate CancerProstate CancerNCT04443062Radboud University Medical Center58
招募中
1 期
Preoperative [177Lu]Lu-PSMAI&T radioligand therapy (PSMA-RLT) for patients with oligometastatic prostatecancer diagnosed using [68Ga]Ga-PSMA-11 PET imaging followed by radical prostatectomy: A Prospective Phase II StudyProstate CancerEUCTR2022-004115-92-ATMedical University of Vienna10