Lutetium-177-PSMA Radioligand Therapy in Advanced Salivary Gland Cancer Patients (NCT04291300) | Clinical Trial Compass
CompletedPhase 2
Lutetium-177-PSMA Radioligand Therapy in Advanced Salivary Gland Cancer Patients
Netherlands12 participantsStarted 2020-05-26
Plain-language summary
Phase 2 pilot study, which evaluates the safety and efficacy of Lutetium-177-PSMA radioligand therapy in advanced salivary gland cancer patients.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* P…
What they're measuring
1
Adverse events measured using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Timeframe: Through study completion, up until 3 years after last patient commences treatment