177Lu-PSMA Radioligand Therapy for advanced salivary gland cancer, a phase II pilot study.

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

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 comorbid 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Efficacy: by objective response rate (ORR)<br /><br>- Progression free survival (PFS)<br /><br>- Overal survival (OS)<br /><br>- Duration of response (DoR)<br /><br>- Quality of life (QoL)<br /><br>- delivered dose<br /><br>- radiation toxicity<br /><br>- to explore differences in tumor mutational burden, immunohistochemical<br /><br>expression profiles and intracellular pathways between responding and<br /><br>non-responding patients</p><br>