Loading clinical trials...

Lutetium-177-PSMA Radioligand Therapy in Advanced Salivary Gland Cancer Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Lutetium-177-PSMA Radioligand Therapy in Advanced Salivary Gland Cancer Patients

Lutetium-177-PSMA Radioligand Therapy for Advanced Salivary Gland Cancer, a Phase II Pilot Study.

NCT04291300•Radboud University Medical Center

Summary

Phase 2 pilot study, which evaluates the safety and efficacy of Lutetium-177-PSMA radioligand therapy in advanced salivary gland cancer patients.

Detailed Description

Rationale: Prostate specific membrane antigen (PSMA) is a transmembrane protein, which is expressed on prostate cancers cells and other malignancies. Recently, several ligands have been developed that target PSMA. Linked to Gallium-68, this enables diagnostic 68Ga-PSMA-PET/CT scans. Linked to Lutetium-177 enables therapeutic 177Lu-PSMA Radioligand therapy. Most research on the diagnostic and therapeutic possibilities of PSMA has been conducted in patients with advanced prostate cancer. This research group investigates whether these findings also apply to salivary gland cancer (SGC), a rare cancer. Previously the investigators conducted a phase II 68Ga-PSMA imaging study (NCT03319641), to evaluate PSMA ligand uptake in locally advanced, recurrent and metastatic (R/M) ACC and SDC (two subtypes of SGC). A relevant PSMA-ligand uptake was observed in 93% of ACC patients and 40% of SDC patients. Therefore we consider 177Lu-PSMA radioligand therapy a potential new treatment option for these subtypes of SGC. Objective: To evaluate the safety and efficacy of 177Lu-PSMA RLT in patients with R/M ACC and SDC with PSMA ligand uptake. Study design: Phase II pilot study, single centre, two cohorts.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have the ability to provide written informed consent.
•Patients must be ≥ 18 years of age.
•Patients must have an ECOG performance status of 0 to 2.
•Patients must have histological, pathological, and/or cytological confirmation of either adenoid cystic carcinoma or salivary duct carcinoma.
•Patients must have incurable, local or regional recurrent or metastatic ACC or SDC.
•Patients with ACC can only participate in case of objective growth in the last three months or complaints due to the disease.
•Patients must have adequate organ function:
•* Sufficient bone marrow capacity as defined by: WBC count (white blood cell) ≥2.5x10\^9/L, PLT (platelet) count ≥100x10\^9/L, Hb ≥6 mmol/L, absolute neutrophil count (ANC) ≥1.5x10\^9/L
•* Adequate liver function as defined by:Total bilirubin ≤1.5 x ULN. For patients known with Gilbert's Syndrome ≤ 3 x ULN is permitted. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN OR ≤5.0 × ULN for patients with liver metastases.
•* Adequate kidney function as defined by:serum creatinine ≤1.5 x ULN or creatinine clearance ≥ 50 mL/min
+2 more criteria

Exclusion Criteria

•Patients whom are pregnant or breast feeding.
•Patients with reproductive potential not implementing adequate contraceptives measures.
•Patients with known brain metastases or cranial epidural disease or intracardial metastases.
•Patients with concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
•Patients with urinary tract obstruction or marked hydronephrosis
•Less than 4 weeks since last myelosuppressive therapy or other radionuclide therapy.
•Concomitant cancer treatments

Locations (1)

Radboudumc

Nijmegen, Gelderland, Netherlands

Key Dates

Start Date

May 26, 2020

Primary Completion Date

February 13, 2023

Completion Date

February 13, 2023

Last Updated

May 10, 2023

Enrollment

ACTUAL participants

Conditions

Salivary Gland CancerSalivary Duct CarcinomaAdenoid Cystic Carcinoma

Interventions

Lutetium-177-PSMA-I&T

DRUG

A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma

NCT06891560

Adenoid Cystic Carcinoma

View study

RECRUITINGPHASE2

Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers

NCT05884320

GlandSalivary Gland Cancers

View study

RECRUITINGPHASE1

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 10, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Lutetium-177-PSMA Radioligand Therapy in Advanced Salivary Gland Cancer Patients

Inclusion Criteria

Exclusion Criteria

A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma

Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Transoral Robotic Surgery in Treating Patients With Benign or Malignant Tumors of the Head and Neck

Drug Screening Using Novel IMD in Salivary and Head and Neck Cancers

Study of Safety and Efficacy of RGT-61159 in Adults With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)