Non-commercial phase 2 clinical trial to evaluate the effectiveness, safety and tolerability of treatment using prostate-specific membrane antigen (PSMA) labeled with 177Lutetium in patients with recurrence and/or metastases in adenoid cystic carcinoma originating from the salivary glands of the head and neck region. Patients with PSMA receptor expression confirmed by PET/CT after administration of 68Ga-PSMA I\&T will be eligible for treatment.
It is planned to enroll 32 patients diagnosed with non-resectable recurrence and/or dissemination in the course of ACC, whose general condition and life expectancy justify qualification for diagnosis using PSMA 68Ga and treatment with lutetium (177Lu) vipivotide-tetraxetan The Study assumes the administration of 6 cycles of treatment (lutetium \[177Lu\] vipivotide-tetraxetan) at 6-week intervals. If toxicity occurs, the activity of the next dose of the preparation will be modified or its next administration will be delayed by a maximum of 4 weeks. After completing 6 cycles of therapy, the participant enters the observation phase, which will last until recurrence of the disease is diagnosed or for 2 years after the end of therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
6 cycles of lutetium (177Lu) vipivotide-tetraxetan with an activity of 200 mCi (7.4 GBq) at intervals of 6 weeks
Maria Sklodowska-Curie National Research Institute of Oncology
Gliwice, Poland
Assessment of the effectiveness of the study treatment
Objective response rate (ORR) - RECIST 1.1 score in CT examination 2 years after completion of treatment
Time frame: 2 years after the end of treatment
Assessment of the effectiveness of the study treatment
Progression free survival
Time frame: Time from the date of initiation of the treatment to the disease progression or death
Assessment of the effectiveness of the study treatment
Overall survival
Time frame: Time from the date of initiation of the treatment to death
Assessment of the effectiveness of the study treatment
Duration of response
Time frame: Time from the date of initiation of the treatment to the disease progression or death
Assessment of quality of life
Assessment of quality of life (according to the EORTC QLQ-C30 and EORTC QLQ-H\&N43 questionnaire)
Time frame: Time from the the date of initiation of treatment to the disease progression or death
Assessment of safety and tolerance
Assessment of safety and tolerance of treatment according to Common Terminology Criteria for Adverse Events v. 5.0
Time frame: Time from the date of initiation of the treatment to disease progression or death
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