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

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ClinicalTrials.gov Identifier: NCT04291300
Recruitment Status : Recruiting
First Posted : March 2, 2020
Last Update Posted : May 28, 2020
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
Radboud University

Tracking Information
First Submitted Date  ICMJE February 28, 2020
First Posted Date  ICMJE March 2, 2020
Last Update Posted Date May 28, 2020
Actual Study Start Date  ICMJE May 26, 2020
Estimated Primary Completion Date May 26, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2020)
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 ]
Safety
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2020)
  • Objective response rate (ORR) [ Time Frame: Through study completion, up until 3 years after last patient commences treatment ]
    Response will be measured according to RECIST version 1.1
  • Progression free survival (PFS) [ Time Frame: Through study completion, up until 3 years after last patient commences treatment ]
    PFS will be defined as time from study enrollment until disease progression or death.
  • Overall survival (OS) [ Time Frame: Through study completion, up until 3 years after last patient commences treatment ]
    OS will be defined as time from study enrollment until date of death of any cause.
  • Duration of response (DoR) [ Time Frame: Through study completion, up until 3 years after last patient commences treatment ]
    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) [ Time Frame: Trough study completion, up until 3 years after last patient commences treatment ]
    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) [ Time Frame: Trough study completion, up until 3 years after last patient commences treatment ]
    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) [ Time Frame: Trough study completion, up until 3 years after last patient commences treatment ]
    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) [ Time Frame: Trough study completion, up until 3 years after last patient commences treatment ]
    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 [ Time Frame: From start of study till last patient commences last SPECT/CT (7 days after first treatment cycle) ]
    Delivered doses will be calculated based on pharmacokinetics in the blood and dosimetry on SPECT/CT imaging.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2020)
  • Objective response rate (ORR) [ Time Frame: Through study completion, up until 3 years after last patient commences treatment ]
    Response will be measured according to RECIST version 1.1
  • Progression free survival (PFS) [ Time Frame: Through study completion, up until 3 years after last patient commences treatment ]
    PFS will be defined as time from study enrollment until disease progression or death.
  • Overall survival (OS) [ Time Frame: Through study completion, up until 3 years after last patient commences treatment ]
    OS will be defined as time from study enrollment until date of death of any cause.
  • Duration of response (DoR) [ Time Frame: Through study completion, up until 3 years after last patient commences treatment ]
    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) [ Time Frame: Trough study completion, up until 3 years after last patient commences treatment ]
    QoL will be assessed using EORTC QLQ-C30 questionnaire.
  • Quality of life (QoL) [ Time Frame: Trough study completion, up until 3 years after last patient commences treatment ]
    QoL will be assessed using EORTC QLQ-H&N43 questionnaire.
  • Quality of life (QoL) [ Time Frame: Trough study completion, up until 3 years after last patient commences treatment ]
    QoL will be assessed using PERFORMANCE STATUS SCALE FOR HEAD & NECK (PSSHN ) questionnaire.
  • Quality of life (QoL) [ Time Frame: Trough study completion, up until 3 years after last patient commences treatment ]
    QoL will be assessed using pain VAS questionnaire.
  • Dosimetry [ Time Frame: From start of study till last patient commences last SPECT/CT (7 days after first treatment cycle) ]
    Delivered doses will be calculated based on pharmacokinetics in the blood and dosimetry on SPECT/CT imaging.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lutetium-177-PSMA Radioligand Therapy in Advanced Salivary Gland Cancer Patients
Official Title  ICMJE Lutetium-177-PSMA Radioligand Therapy for Advanced Salivary Gland Cancer, a Phase II Pilot Study.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Condition  ICMJE
  • Salivary Gland Cancer
  • Salivary Duct Carcinoma
  • Adenoid Cystic Carcinoma
Intervention  ICMJE Drug: Lutetium-177-PSMA-I&T
4 cycles of 7.4 GBq 177Lu-PSMA every 6 weeks.
Other Name: Lutetium-177 Prostate Specific Membrane Antigen
Study Arms  ICMJE Experimental: Lutetium treatment
Drug: Lutetium-177-PSMA-I&T, 4 cycles of 7.4 GBq intravenously, every 6 weeks.
Intervention: Drug: Lutetium-177-PSMA-I&T
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 28, 2020)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2024
Estimated Primary Completion Date May 26, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04291300
Other Study ID Numbers  ICMJE MOHN18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE Dutch Cancer Society
Investigators  ICMJE Not Provided
PRS Account Radboud University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP