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

STATUS

Recruiting
participants needed

10
sponsor

Radboud University

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Updated on 19 February 2024

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cancer

ct scan

measurable disease

metastasis

gilbert's syndrome

neutrophil count

liver metastasis

adenoid cystic carcinoma

salivary gland cancer

Summary

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

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.

Details

Condition	Adenocarcinoma, Adenocarcinoma, Adenoid Cystic Carcinoma, Oral Neoplasm, salivary gland cancer, Salivary Duct Carcinoma
Age	18years - 100years
Treatment	Lutetium-177-PSMA-I&T
Clinical Study Identifier	NCT04291300
Sponsor	Radboud University
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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
	Patients must have measurable disease at baseline. Defined as 1 lesion 2 cm (long axis) that is present on baseline CT
	Patients must have a positive 68Ga-PSMA PET/CT scan, defined by at least one lesion 1.5 cm (long axis) with a ligand uptake above liver level
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

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