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

Primary Purpose

Salivary Gland Cancer, Salivary Duct Carcinoma, Adenoid Cystic Carcinoma

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Lutetium-177-PSMA-I&T
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Salivary Gland Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 co-morbid 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

Sites / Locations

  • Radboudumc

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lutetium treatment

Arm Description

Drug: Lutetium-177-PSMA-I&T, 4 cycles of 7.4 GBq intravenously, every 6 weeks.

Outcomes

Primary Outcome Measures

Adverse events measured using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Safety

Secondary Outcome Measures

Objective response rate (ORR)
Response will be measured according to RECIST version 1.1
Progression free survival (PFS)
PFS will be defined as time from study enrollment until disease progression or death.
Overall survival (OS)
OS will be defined as time from study enrollment until date of death of any cause.
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
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.
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.
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.
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.
Dosimetry
Delivered doses will be calculated based on pharmacokinetics in the blood and dosimetry on SPECT/CT imaging.

Full Information

First Posted
February 28, 2020
Last Updated
May 9, 2023
Sponsor
Radboud University Medical Center
Collaborators
Dutch Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT04291300
Brief Title
Lutetium-177-PSMA Radioligand Therapy in Advanced Salivary Gland Cancer Patients
Acronym
LUPSA
Official Title
Lutetium-177-PSMA Radioligand Therapy for Advanced Salivary Gland Cancer, a Phase II Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 26, 2020 (Actual)
Primary Completion Date
February 13, 2023 (Actual)
Study Completion Date
February 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Dutch Cancer Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Salivary Gland Cancer, Salivary Duct Carcinoma, Adenoid Cystic Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Phase II pilot study, single centre, two cohorts. Cohort 1: Patients with R/M ACC Cohort 2: Patients with R/M SDC
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lutetium treatment
Arm Type
Experimental
Arm Description
Drug: Lutetium-177-PSMA-I&T, 4 cycles of 7.4 GBq intravenously, every 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Lutetium-177-PSMA-I&T
Other Intervention Name(s)
Lutetium-177 Prostate Specific Membrane Antigen
Intervention Description
4 cycles of 7.4 GBq 177Lu-PSMA every 6 weeks.
Primary Outcome Measure Information:
Title
Adverse events measured using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Description
Safety
Time Frame
Through study completion, up until 3 years after last patient commences treatment
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Response will be measured according to RECIST version 1.1
Time Frame
Through study completion, up until 3 years after last patient commences treatment
Title
Progression free survival (PFS)
Description
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
Title
Overall survival (OS)
Description
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
Title
Duration of response (DoR)
Description
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
Title
Quality of life (QoL)
Description
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.
Time Frame
Trough study completion, up until 3 years after last patient commences treatment
Title
Quality of life (QoL)
Description
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
Title
Quality of life (QoL)
Description
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
Title
Quality of life (QoL)
Description
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
Title
Dosimetry
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 co-morbid 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
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6500HB
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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