Trials / Completed
CompletedNCT04291300
Lutetium-177-PSMA Radioligand Therapy in Advanced Salivary Gland Cancer Patients
Lutetium-177-PSMA Radioligand Therapy for Advanced Salivary Gland Cancer, a Phase II Pilot Study.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Radboud University Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Phase 2 pilot study, which evaluates the safety and efficacy of Lutetium-177-PSMA radioligand therapy in advanced salivary gland cancer patients.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lutetium-177-PSMA-I&T | 4 cycles of 7.4 GBq 177Lu-PSMA every 6 weeks. |
Timeline
- Start date
- 2020-05-26
- Primary completion
- 2023-02-13
- Completion
- 2023-02-13
- First posted
- 2020-03-02
- Last updated
- 2023-05-10
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT04291300. Inclusion in this directory is not an endorsement.