The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a Specialized Prostate-specific Membrane Antigen (PSMA) Labeled with Lutetium177, in Patients with Recurrent And/or Metastatic Adenoid Cystic Carcinoma Originating from the Salivary Glands - an Open, Non-commercial Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- Lutetium (177Lu) vipivotide tetraxetan
- Conditions
- Adenoid Cystic Carcinoma
- Sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Assessment of the effectiveness of the study treatment
- Status
- Withdrawn
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Experimental
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.
Intervention: Lutetium (177Lu) vipivotide tetraxetan
Outcomes
Primary Outcomes
Assessment of the effectiveness of the study treatment
Time Frame: 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 Outcomes
- Assessment of quality of life(Time from the the date of initiation of treatment to the disease progression or death)
- Assessment of safety and tolerance(Time from the date of initiation of the treatment to disease progression or death)
- Assessment of the effectiveness of the study treatment(Time from the date of initiation of the treatment to the disease progression or death)