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Salivary Gland CancerPhase 2LUPSANCT04291300

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

A Phase 2 study testing Lutetium-177-PSMA-I&T in people with Salivary Gland Cancer and Salivary Duct Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase 2 pilot study, which evaluates the safety and efficacy of Lutetium-177-PSMA radioligand therapy in advanced salivary gland cancer patients. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lutetium-177-PSMA-I&T
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteNetherlands
Study dates
26 May 2020to 13 Feb 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboudumc

    Nijmegen, Gelderland, 6500HB

Other trials in Netherlands

About this study

Official title: Lutetium-177-PSMA Radioligand Therapy for Advanced Salivary Gland Cancer, a Phase II Pilot Study.

Phase 2 pilot study, which evaluates the safety and efficacy of Lutetium-177-PSMA radioligand therapy in advanced salivary gland cancer patients.

Read the 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.

Being tested
Lutetium-177-PSMA-I&T
Medical subject headings
Salivary Gland Neoplasms, Carcinoma, Adenoid Cystic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lutetium-177-PSMA-I&TDrug

    Also called Lutetium-177 Prostate Specific Membrane Antigen

    4 cycles of 7.4 GBq 177Lu-PSMA every 6 weeks.

Study groups in NCT04291300
Study groupRoleWhat they receive
Lutetium treatmentExperimentalDrug: Lutetium-177-PSMA-I\&T, 4 cycles of 7.4 GBq intravenously, every 6 weeks.
Receives: Drug: Lutetium-177-PSMA-I&T

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Safety

    Measured: Through study completion, up until 3 years after last patient commences treatment

Secondary outcomes (9)

  1. Objective response rate (ORR)

    Response will be measured according to RECIST version 1.1

    Measured: Through study completion, up until 3 years after last patient commences treatment

  2. Progression free survival (PFS)

    PFS will be defined as time from study enrollment until disease progression or death.

    Measured: Through study completion, up until 3 years after last patient commences treatment

  3. Overall survival (OS)

    OS will be defined as time from study enrollment until date of death of any cause.

    Measured: Through study completion, up until 3 years after last patient commences treatment

  4. 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

    Measured: Through study completion, up until 3 years after last patient commences treatment

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. Dosimetry

    Delivered doses will be calculated based on pharmacokinetics in the blood and dosimetry on SPECT/CT imaging.

    Measured: From start of study till last patient commences last SPECT/CT (7 days after first treatment cycle)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2020
  2. Study start26 May 2020
  3. Primary completion13 Feb 2023
  4. Study completion13 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04291300
Sponsor's protocol ID
MOHN18
Acronym
LUPSA
Status last verified
May 2023
First submitted
28 Feb 2020
Last updated
10 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lutetium-177-PSMA-I&T in people with Salivary Gland Cancer and Salivary Duct Carcinoma, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events measured using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (time frame: Through study completion, up until 3 years after last patient commences treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04291300.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.

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