Phase 2 pilot study, which evaluates the safety and efficacy of Lutetium-177-PSMA radioligand therapy in advanced salivary gland cancer patients.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
4 cycles of 7.4 GBq 177Lu-PSMA every 6 weeks.
Radboudumc
Nijmegen, Gelderland, Netherlands
Adverse events measured using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Safety
Time frame: Through study completion, up until 3 years after last patient commences treatment
Objective response rate (ORR)
Response will be measured according to RECIST version 1.1
Time frame: Through study completion, up until 3 years after last patient commences treatment
Progression free survival (PFS)
PFS will be defined as time from study enrollment until disease progression or death.
Time frame: Through study completion, up until 3 years after last patient commences treatment
Overall survival (OS)
OS will be defined as time from study enrollment until date of death of any cause.
Time frame: Through study completion, up until 3 years after last patient commences treatment
Duration of response (DoR)
Only patients with complete remission or partial response will be included in the assessment of DoR. DoR is defined as time from study enrollment until disease progression or death
Time frame: Through study completion, up until 3 years after last patient commences treatment
Quality of life (QoL)
QoL will be assessed using EORTC QLQ-C30 questionnaire. This is the core questionnaire for assessing health related quality of life of cancer patients participating in clinical trials. It contains 30 items and incorporates a global health status scale, five functional scales, three symptom scales, and several single items assessing additional symptoms. All of the scales and single-item measures range from 0-100. A high score for global health status represents a high QoL, a high score in functional scale represents a high/healthy level of functioning, a high score for a symptom scale/item represents a high level of symptomatology/problems.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Trough study completion, up until 3 years after last patient commences treatment
Quality of life (QoL)
QoL will be assessed using EORTC QLQ-H\&N43 questionnaire. This is an additional questionnaire to assess health related topics relevant for head and neck cancer patients. The module contains 43 questions, all symtom scales or symptom items.All of the scale/item measures range from 0-100. For all scales/items higher scores indicate more problems.
Time frame: Trough study completion, up until 3 years after last patient commences treatment
Quality of life (QoL)
QoL will be assessed using performance status scale for head\&neck cancer patients (PSS-HN). It contains 3 items, each randing from 0-100. These items are rated by the health professional. A high score indicates a high performance status.
Time frame: Trough study completion, up until 3 years after last patient commences treatment
Quality of life (QoL)
QoL will be assessed using pain visual analogue scale (VAS) questionnaire. This include two questions: the average pain during the past week and the worst pain during the past week. Both questions range from 0-100, a higher score indicates more pain.
Time frame: Trough study completion, up until 3 years after last patient commences treatment
Dosimetry
Delivered doses will be calculated based on pharmacokinetics in the blood and dosimetry on SPECT/CT imaging.
Time frame: From start of study till last patient commences last SPECT/CT (7 days after first treatment cycle)