The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a PSMA-Lu177, in Patients with ACC- an Open, Non-commercial Clinical Trial
- Conditions
- Adenoid Cystic Carcinoma
- Interventions
- Registration Number
- NCT06199453
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Lutetium (177Lu) vipivotide tetraxetan Treatment will consist of administration of 6 cycles of lutetium (177Lu) vipivotide-tetraxetan with an activity of 200 mCi (7.4 GBq) at intervals of 6 weeks.
- Primary Outcome Measures
Name Time Method Assessment of the effectiveness of the study treatment 2 years after the end of treatment Objective response rate (ORR) - RECIST 1.1 score in CT examination 2 years after completion of treatment
- Secondary Outcome Measures
Name Time Method Assessment of quality of life Time from the the date of initiation of treatment to the disease progression or death Assessment of quality of life (according to the EORTC QLQ-C30 and EORTC QLQ-H\&N43 questionnaire)
Assessment of safety and tolerance Time from the date of initiation of the treatment to disease progression or death Assessment of safety and tolerance of treatment according to Common Terminology Criteria for Adverse Events v. 5.0
Assessment of the effectiveness of the study treatment Time from the date of initiation of the treatment to the disease progression or death Duration of response
Trial Locations
- Locations (1)
Maria Sklodowska-Curie National Research Institute of Oncology
🇵🇱Gliwice, Poland