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

NCT04291300 | Completed Phase 2 DMC

• 1 other identifier: MOHN18
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Salivary Gland Cancer; Salivary Duct Carcinoma; Adenoid Cystic Carcinoma

Outcome Measures

Primary Outcomes (1)

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

  Safety

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

Secondary Outcomes (9)

• Objective response rate (ORR)

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

• Progression free survival (PFS)

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

• Overall survival (OS)

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

• Duration of response (DoR)

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

• Quality of life (QoL)

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

Study Arms (1)

Lutetium treatment

EXPERIMENTAL

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

Drug: Lutetium-177-PSMA-I&T

Interventions

Lutetium-177-PSMA-I&T DRUG

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

Also known as: Lutetium-177 Prostate Specific Membrane Antigen

Lutetium treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Dutch Cancer Society: collaborator

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500HB, Netherlands

Location

MeSH Terms

Conditions

Salivary Gland Neoplasms; Carcinoma, Adenoid Cystic

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase II pilot study, single centre, two cohorts. Cohort 1: Patients with R/M ACC Cohort 2: Patients with R/M SDC

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 2, 2020
• Study Start: May 26, 2020
• Primary Completion: February 13, 2023
• Study Completion: February 13, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

NL (1)