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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

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

NCT ID

NCT04291300

First Posted

February 28, 2020

Last Updated

May 9, 2023

Sponsor

Radboud University Medical Center

Collaborators

Dutch Cancer Society

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

Studies a U.S. FDA-regulated Device Product

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

Time Frame

Trough study completion, up until 3 years after last patient commences treatment

Title

Quality of life (QoL)

Description

Time Frame

Trough study completion, up until 3 years after last patient commences treatment

Title

Quality of life (QoL)

Description

Time Frame

Trough study completion, up until 3 years after last patient commences treatment

Title

Quality of life (QoL)

Description

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

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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