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

Phase 1

• Conditions: Adenoid cystic carcinoma; MedDRA version: 21.0Level: PTClassification code: 10073370Term: Adenoid cystic carcinoma of salivary gland Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-504699-73-00
• Lead Sponsor: arodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Giving written informed consent to participate in the study., Patients with unresectable, locoregionally advanced or metastatic, histopathologically proven Adenoid Cystic Carcinoma of salivary glands., Age over 18 years., WHO Performance Status 0 to 2., 68Ga-PSMA PET/CT proven expression of PSMA; a positive result is considered as a qualitative assessment equal or greater than accumulation in functional liver., Progression of disease confirmed by imaging scans according to RECIST 1.1 criteria., Adequate function of: Bone marrow - neutrophils >1500x109/L; thrombocytes >150 000x109/L, hemoglobin >9 g/dl; Liver - bilirubin <2xULN (upper limit of normal range); aminotransferase <3xULN (patients with liver metastases <5xULN); Kidneys - eGFR >50 ml/min; Albumins >2,5 mg/ml, In women with procreative ability: confirmed negative pregnancy test result and consent to the implementation of double barrier contraception method., In men with procreative ability: consent to the implementation of double barrier contraception method.

Exclusion Criteria

Pregnancy or breastfeeding., Lack of effective contraception in childbearing age., Patients with brain, cerebral meninges or heart metastases., Severe or significant concomitant disease in the investigator's assessment., Urinary tract obstruction or/and hydronephrosis., Concurrent anticancer treatment., Myelosuppressive or nuclear treatment within 4 weeks before enrollment to the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified