Adenoid Cystic Carcinoma
Conditions
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.
Interventions
6 cycles of lutetium (177Lu) vipivotide-tetraxetan with an activity of 200 mCi (7.4 GBq) at intervals of 6 weeks
Sponsors
Maria Sklodowska-Curie National Research Institute of Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the effectiveness of the study treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the effectiveness of the study treatment | Time from the date of initiation of the treatment to the disease progression or death | Progression free survival |
| Assessment of quality of life | Time from the the date of initiation of treatment to the disease progression or death | Assessment of quality of life (according to the EORTC QLQ-C30 and EORTC QLQ-H&N43 questionnaire) |
| Assessment of safety and tolerance | Time from the date of initiation of the treatment to disease progression or death | Assessment of safety and tolerance of treatment according to Common Terminology Criteria for Adverse Events v. 5.0 |
Countries
Poland
Outcome results
None listed