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

  • STATUS
    Recruiting
  • End date
    May 1, 2025
  • participants needed
    15
  • sponsor
    Radboud University
Updated on 6 October 2021
ct scan
cancer
measurable disease
neutrophil count
pet scan

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, Oral Cavity Cancer, Oral Neoplasm, Oral Cancer, Salivary Duct Carcinoma, salivary gland cancer, Malignant Adenoma, Adenoid Cystic Carcinoma
Treatment Lutetium-177-PSMA-I&T
Clinical Study IdentifierNCT04291300
SponsorRadboud University
Last Modified on6 October 2021

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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