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Trial Title:
The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a PSMA-Lu177, in Patients With ACC- an Open, Non-commercial Clinical Trial
NCT ID:
NCT06199453
Condition:
Adenoid Cystic Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Adenoid Cystic
1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lutetium (177Lu) vipivotide tetraxetan
Description:
6 cycles of lutetium (177Lu) vipivotide-tetraxetan with an activity of 200 mCi (7.4 GBq)
at intervals of 6 weeks
Arm group label:
Experimental
Other name:
Pluvicto 1 000 MBq/mL
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Maria Sklodowska-Curie National Research Institute of Oncology
Address:
City:
Gliwice
Zip:
44-102
Country:
Poland
Start date:
January 2024
Completion date:
November 2027
Lead sponsor:
Agency:
Maria Sklodowska-Curie National Research Institute of Oncology
Agency class:
Other
Source:
Maria Sklodowska-Curie National Research Institute of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06199453
