The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a PSMA-Lu177, in Patients With ACC- an Open, Non-commercial Clinical Trial

Adenoid Cystic Carcinoma Clinical Trial

— LuRM_ACC/2023  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06199453
• Other study ID #: LuRM_ACC/2023
• Secondary ID: EU CT 2023-50469
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2024
• Est. completion date: November 2027

Study information

• Verified date: November 2023
• Source: Maria Sklodowska-Curie National Research Institute of Oncology
• Contact: Marek Kentnowski
• Phone: 48322788319
• Email: marek.kentnowski[@]gliwice.nio.gov.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: November 2027
• Est. primary completion date: November 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoid Cystic Carcinoma
• Carcinoma
• Carcinoma, Adenoid Cystic

Intervention

Drug:
• Lutetium (177Lu) vipivotide tetraxetan
6 cycles of lutetium (177Lu) vipivotide-tetraxetan with an activity of 200 mCi (7.4 GBq) at intervals of 6 weeks

Locations

Country	Name	City	State
Poland	Maria Sklodowska-Curie National Research Institute of Oncology	Gliwice

Sponsors (1)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie National Research Institute of Oncology

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years after the end of treatment
Secondary	Assessment of the effectiveness of the study treatment	Progression free survival	Time from the date of initiation of the treatment to the disease progression or death
Secondary	Assessment of the effectiveness of the study treatment	Overall survival	Time from the date of initiation of the treatment to death
Secondary	Assessment of the effectiveness of the study treatment	Duration of response	Time from the date of initiation of the treatment to the disease progression or death
Secondary	Assessment of quality of life	Assessment of quality of life (according to the EORTC QLQ-C30 and EORTC QLQ-H&N43 questionnaire)	Time from the the date of initiation of treatment to the disease progression or death
Secondary	Assessment of safety and tolerance	Assessment of safety and tolerance of treatment according to Common Terminology Criteria for Adverse Events v. 5.0	Time from the date of initiation of the treatment to disease progression or death