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Study on Lutetium (177Lu) Zadavotide Guraxetan for Patients with Recurrent Grade 3 and Grade 4 Glioma

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What is this study about?

This clinical trial is focused on studying a type of brain cancer known as recurrent grade 3 and grade 4 glioma. The treatment being tested is called 177Lu PSMA I&T solution for injection, which is a special kind of medicine that is injected into the bloodstream. This medicine contains a radioactive substance called lutetium (177Lu) zadavotide guraxetan, which is designed to target and treat cancer cells.

The purpose of the study is to evaluate how safe and tolerable this treatment is for patients, as well as how effective it is in treating the cancer. Participants in the study will receive the treatment through an intravenous infusion, which means the medicine is given directly into a vein. The study will monitor patients over a period of time to see how they respond to the treatment and to check for any side effects. The study will also look at how the treatment affects the cancer’s progression and the overall survival of the patients.

Throughout the study, various assessments will be conducted, including imaging tests like MRI to evaluate the tumor’s response to the treatment. The study will also assess the impact of the treatment on patients’ quality of life and their ability to perform daily activities. The goal is to gather comprehensive information about the treatment’s benefits and any potential risks, helping to determine its suitability for treating this type of brain cancer.

1 enrollment

Upon joining the clinical trial, the first step involves confirming eligibility. This includes having a previous diagnosis of grade 3 or grade 4 glioma, being at least 18 years old, and having a life expectancy of more than 12 weeks.

A negative pregnancy test is required for women of childbearing potential, and written informed consent must be provided.

2 initial assessment

An initial assessment is conducted to evaluate the current health status. This includes a radiological examination using MRI to confirm tumor relapse or progression.

The Karnofsky performance status, which measures the ability to perform daily activities, must be at least 70%.

3 treatment cycle

The treatment involves receiving the medication 177Lu PSMA I&T solution for injection through an intravenous infusion. This is administered in cycles lasting 6 to 8 weeks.

During each cycle, no other tumor-directed treatments should be received.

4 monitoring and evaluation

Throughout the trial, regular monitoring is conducted to assess safety and tolerability. This includes tracking any adverse events and changes in health status.

Efficacy is evaluated by measuring progression-free survival over 6 months and overall survival over 1 year.

5 follow-up assessments

Follow-up assessments are performed to evaluate the radiation dose to the tumor and critical organs. This involves calculating absorbed doses to various organs.

Additional evaluations include tumor response using MRI, neurologic exams, and assessments of quality of life and performance status.

Who Can Join the Study?

  • Must have a previous diagnosis of a WHO grade 3 or grade 4 glioma. This means a specific type of brain tumor that has been confirmed by a doctor.
  • Women who can have children must use effective birth control. This includes women who have started having periods and have not yet gone through menopause, unless they have had surgery to permanently prevent pregnancy (such as removal of the uterus or ovaries).
  • Must agree not to receive any other treatment aimed at the tumor during each treatment cycle, which lasts 6-8 weeks.
  • Must have a tumor that has been confirmed to have returned or grown, at least 12 weeks after finishing radiation therapy, or if there is a suspicion of recurrence that makes participation in the study appropriate.
  • Must be 18 years old or older.
  • Must provide written consent to participate in the study.
  • Women must have a negative pregnancy test within 14 days before joining the study.
  • Must have a life expectancy of more than 12 weeks.
  • Must have a Karnofsky performance status of 70% or higher, meaning they must be able to take care of themselves after receiving treatment.
  • Must show high tumor uptake on a specific diagnostic imaging test using 68Ga-PSMA.
  • The tumor must not be suitable for further radiation therapy or surgery, and the treating doctor must believe there are no better treatment options available.

Who Cannot Join the Study?

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another type of cancer in the past, unless it was treated and has not come back for at least 5 years.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who are currently participating in another clinical trial.
  • Patients who have an allergy to the study medication or its ingredients.
  • Patients who have not recovered from side effects of previous treatments.
  • Patients with a history of certain heart conditions.
  • Patients with uncontrolled high blood pressure.
  • Patients with active infections that require treatment.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
St. Olavs Hospital HF Trondheim Norway

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

Trial status

Country Status Recruitment Start
Norway Norway
Not yet recruiting
04.04.2023

Trial locations

Investigated drugs:

177Lu-PSMA is a type of targeted therapy used in this clinical trial. It is designed to treat patients with recurrent or progressed grade 3 and grade 4 glioma, which are types of brain tumors. This therapy works by attaching a radioactive substance, Lutetium-177, to a molecule that specifically targets cancer cells. The radioactive part helps to destroy the cancer cells while minimizing damage to the surrounding healthy tissue. The trial aims to assess how safe and tolerable this treatment is for patients, as well as how effective it is in reducing the size or growth of the tumors.

Investigated diseases:

Recurrent Grade 3 and Grade 4 Glioma – Glioma is a type of tumor that occurs in the brain and spinal cord, originating from glial cells. Grade 3 gliomas, also known as anaplastic gliomas, are malignant and grow more aggressively than lower-grade tumors. Grade 4 gliomas, commonly referred to as glioblastomas, are the most aggressive form, characterized by rapid growth and a tendency to infiltrate surrounding brain tissue. These tumors can cause a variety of neurological symptoms depending on their location, such as headaches, seizures, and cognitive or motor impairments. Recurrent gliomas are those that have returned after initial treatment, often exhibiting more aggressive behavior. The progression of these tumors involves increased growth and potential spread within the central nervous system.

Trial ID:
2024-518495-31-00
Protocol code:
Glioma Theranostics
NCT ID:
NCT05644080
Trial Phase:
Therapeutic exploratory (Phase II)

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