Radioactive labeled PSMA therapy for advanced salivary gland cancer
- Conditions
- Salivary gland cancer. More specifically two subtypes: adenoid cystic carcinoma and salivary duct carcinoma.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-003857-27-NL
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 10
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method