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Study on the Safety and Effectiveness of Lutetium (177Lu) Vipivotide Tetraxetan for Patients with Recurrent or Metastatic Adenoid Cystic Carcinoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called adenoid cystic carcinoma, which originates from the salivary glands. The treatment being tested involves a specialized substance known as prostate-specific membrane antigen (PSMA) that is labeled with a radioactive element called Lutetium177. This treatment is delivered as a solution for injection or infusion, known by the name Pluvicto.

The purpose of the study is to evaluate the effectiveness, safety, and tolerability of this treatment in patients who have recurrent or metastatic adenoid cystic carcinoma. The study will involve monitoring patients over a period of time to assess how well the treatment works and how it affects their health. Patients will receive the treatment through an intravenous infusion, which means it will be administered directly into a vein.

Throughout the study, various aspects of the patients’ health will be observed, including their response to the treatment and any side effects they may experience. The study aims to provide valuable information on how this treatment can be used to manage adenoid cystic carcinoma, with a focus on improving the quality of life for those affected by this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and imaging scans to confirm the presence of adenoid cystic carcinoma.

Eligibility criteria include being over 18 years old, having a specific performance status, and confirmed disease progression.

2 treatment administration

The treatment involves the administration of Pluvicto, a solution containing lutetium (177lu) vipivotide tetraxetan. This is given through an intravenous infusion.

The dosage and frequency of administration are determined by the study protocol and the patient’s specific condition.

3 monitoring and evaluation

Throughout the treatment, regular monitoring is conducted to assess safety and tolerability. This includes evaluating any side effects according to established criteria.

Imaging scans and other tests are performed to assess the response to treatment and progression of the disease.

4 follow-up assessments

After completing the treatment, follow-up assessments are conducted to evaluate long-term outcomes such as progression-free survival and overall survival.

Quality of life is also assessed using specific questionnaires designed for this purpose.

5 end of study

The study is estimated to conclude by February 28, 2028. Final assessments will be conducted to gather comprehensive data on the treatment’s effectiveness and impact on quality of life.

Who Can Join the Study?

  • Provide written informed consent to participate in the study.
  • Have a type of cancer called Adenoid Cystic Carcinoma in the salivary glands that cannot be removed by surgery, is advanced in the local area, or has spread to other parts of the body. This must be confirmed by examining tissue samples under a microscope.
  • Be over 18 years old.
  • Have a WHO Performance Status between 0 and 2, which is a way to measure how well you can perform daily activities.
  • Show a positive result for PSMA expression using a special imaging test called 68Ga-PSMA PET/CT. This means the test shows a certain level of activity in the liver.
  • Have disease progression confirmed by imaging scans according to RECIST 1.1 criteria, which is a standard way to measure how cancer responds to treatment.
  • Have adequate function of the following:
    • Bone marrow: Neutrophils (a type of white blood cell) greater than 1500 per microliter; platelets (cells that help with blood clotting) greater than 150,000 per microliter; hemoglobin (a protein in red blood cells) greater than 9 grams per deciliter.
    • Liver: Bilirubin (a substance made by the liver) less than twice the upper limit of normal; aminotransferase (an enzyme) less than three times the upper limit of normal, or less than five times if there are liver metastases.
    • Kidneys: Estimated glomerular filtration rate (eGFR, a measure of kidney function) greater than 50 milliliters per minute; albumins (a type of protein) greater than 2.5 milligrams per milliliter.
  • For women who can have children: Have a confirmed negative pregnancy test and agree to use a double barrier method of contraception.
  • For men who can have children: Agree to use a double barrier method of contraception.

Who Cannot Join the Study?

  • Patients with other types of cancer besides adenoid cystic carcinoma cannot participate. Adenoid cystic carcinoma is a specific type of cancer that affects certain glands in the body.
  • Patients who are not within the specified age range for the study cannot participate. The study is designed for certain age groups only.
  • Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate cannot join the study.
  • Patients who are pregnant or breastfeeding may not be eligible to participate, as the study may involve treatments that could affect the baby.
  • Patients who have participated in another clinical trial recently may not be eligible, as this could affect the results of the study.
  • Patients with certain medical conditions that could interfere with the study treatment or outcomes may not be eligible to participate.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not recruiting
01.07.2023

Trial locations

Investigated drugs:

Lutetium-177 PSMA is a specialized treatment used in this clinical trial. It involves a radioactive substance, Lutetium-177, which is attached to a molecule that specifically targets prostate-specific membrane antigen (PSMA). This treatment is designed to deliver radiation directly to cancer cells, particularly in patients with recurrent or metastatic adenoid cystic carcinoma originating from the salivary glands. The goal is to evaluate the effectiveness, safety, and tolerability of this targeted therapy.

Investigated diseases:

Adenoid cystic carcinoma – Adenoid cystic carcinoma is a rare type of cancer that typically arises in the salivary glands, but it can also occur in other areas of the body such as the breast, skin, or respiratory tract. It is characterized by slow growth and a tendency to spread along nerves, which can lead to pain or numbness. The disease often presents as a painless mass or lump, and it may not cause symptoms until it has grown significantly. Over time, adenoid cystic carcinoma can invade surrounding tissues and spread to distant sites, such as the lungs. Despite its slow progression, it can be challenging to manage due to its tendency to recur after treatment.

Trial ID:
2023-504699-73-00
Protocol code:
LuRM_ACC/2023
Trial Phase:
Therapeutic exploratory (Phase II)

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