Clinical trial NCT06199453: The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a PSMA-Lu177, in Patients with ACC- an Open, Non-commercial Clinical Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Adenoid Cystic Carcinoma
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

* Signing the informed consent form to participate in the study
* Patients with inoperable, locoregionally advanced or metastatic, histopathologically confirmed adenoid cystic carcinoma of salivary gland
* Age over 18 years
* WHO performance status 0 to 2
* PSMA expression confirmed by PET/CT using 68Ga-PSMA;
* Presence of measurable disease according to RECIST 1.1 criteria
* Adequate function of: bone marrow, liver, kidneys:

bone marrow: neutrophils \>1500x10\^9/L; thrombocytes \>150,000x10\^9/L, hemoglobin \>9 g/dl liver: bilirubin \<2xULN; aminotransferases \<3xULN (in patients with liver metastases \<5xULN) kidney: eGFR \>50 ml/min albumin \>2.5 mg/ml

* For women of reproductive age: confirmed negative pregnancy test
* The need to use of a highly effective method of contraception

Exclusion criteria:

* Pregnancy or breastfeeding
* Lack of effective contraception during childbearing age
* Patients with metastases to the brain, meninges or heart
* Severe or significant additional diseases in the opinion of the investigator
* Urinary tract obstruction and/or hydronephrosis.
* Concomitant treatment of another cancer
* Myelosuppressive or nuclear treatment later than 4 weeks after qualification
* Previous treatment with 177Lutetium-labeled PSMA

Primary outcomes:
measure: Assessment of the effectiveness of the study treatment
timeFrame: 2 years after the end of treatment
Secondary outcomes:
measure: Assessment of the effectiveness of the study treatment
timeFrame: Time from the date of initiation of the treatment to the disease progression or death
measure: Assessment of the effectiveness of the study treatment
timeFrame: Time from the date of initiation of the treatment to death
measure: Assessment of the effectiveness of the study treatment
timeFrame: Time from the date of initiation of the treatment to the disease progression or death
measure: Assessment of quality of life
timeFrame: Time from the the date of initiation of treatment to the disease progression or death
measure: Assessment of safety and tolerance
timeFrame: Time from the date of initiation of the treatment to disease progression or death
Other outcomes:
Locations:
city: Gliwice
country: Poland
facility: Maria Sklodowska-Curie National Research Institute of Oncology
Study officials:
References: