TheranosticTrials.org

Clinical Trial · NCT04291300

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

Overview

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

Sponsor

Radboud University Medical Center

Phase

Phase 2

ClinicalTrials.gov

NCT04291300

Drug / Compound

PSMA-I&T

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: DOTAGA

Eligibility

Inclusion

  • Patients must have histological, pathological, and/or cytological confirmation of either adenoid cystic carcinoma or salivary duct carcinoma.
  • Patients must have adequate organ function:
  • 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.
  • Patients must have an ECOG performance status of 0 to 2.
  • Patients must have measurable disease at baseline. Defined as ≥ 1 lesion ≥ 2 cm (long axis) that is present on baseline CT.
  • Patients with ACC can only participate in case of objective growth in the last three months or complaints due to the disease.
  • 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 kidney function as defined by:serum creatinine ≤1.5 x ULN or creatinine clearance ≥ 50 mL/min
  • Patients must have incurable, local or regional recurrent or metastatic ACC or SDC.
  • 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.

Exclusion

  • Patients with reproductive potential not implementing adequate contraceptives measures.
  • Concomitant cancer treatments
  • 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.
  • Less than 4 weeks since last myelosuppressive therapy or other radionuclide therapy.
  • Patients with urinary tract obstruction or marked hydronephrosis
  • Patients with known brain metastases or cranial epidural disease or intracardial metastases.
  • Patients whom are pregnant or breast feeding.