Salivary gland cancer. More specifically two subtypes: adenoid cystic carcinoma and salivary duct carcinoma.
Conditions
Interventions
Product Name: Lutetium-177-PSMA-I&T
Product Code: Lutetium-177-PSMA-I&T
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PSMA I&T
Other descriptive name: PSMA I&T
Concentration unit: µ
Sponsors
Radboudumc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of lutetium-177-PSMA radioligand therapy in patients with advanced adenoid cystic carcinoma or salivary duct carcinoma with PSMA ligand uptake.;Secondary Objective: - Assess the progression free survival (PFS). - Assess the overall survival (OS). - Assess the duration of response (DoR). - To calculate the dose delivered by 177Lu-PSMA RLT. - To determine the radiation toxicity (focusing on radiation doses to organs at risk) of 177Lu-PSMA RLT. - Assess the QoL of patients treated with 177Lu-PSMA RLT using EORTC questionnaires. - To explore differences in tumor mutational burden, immunohistochemical expression profiles and intracellular pathways between responding and non-responding patients. ;Primary end point(s): Safety: Safety and tolerability will be studied by analysis of adverse events, physical examinations, vital signs, Eastern Cooperative Oncology Group (ECOG) per-formance status, and laboratory-abnormality assessments. Severity of adverse events will be rated by investigators by use of the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0;Timepoint(s) of evaluation of this end point: During study and at 6 monhts, 12 months and 3 years after start of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Efficacy: by objective response rate (ORR) - Progression free survival (PFS) - Overal survival (OS) - Duration of response (DoR) - Quality of life (QoL) - delivered dose - radiation toxicity - to explore differences in tumor mutational burden, immunohistochemical expression profiles and intracellular pathways between responding and non-responding patients ;Timepoint(s) of evaluation of this end point: During study and at 6 monhts, 12 months and 3 years after start of study. | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Medical Oncology
Radboud university medical center
Outcome results
None listed