Status:
WITHDRAWN
The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a PSMA-Lu177, in Patients with ACC- an Open, Non-commercial Clinical Trial
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Conditions:
Adenoid Cystic Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 recu...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06199453
Start Date
January 1 2024
End Date
November 1 2027
Last Update
February 10 2025
Active Locations (1)
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1
Maria Sklodowska-Curie National Research Institute of Oncology
Gliwice, Poland, 44-102