Study on Lutathera for Treating Inoperable, Worsening Meningioma After Radiation Therapy

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04082520

Provider View

This clinical trial is testing the effectiveness and safety of Lutathera, a radioactive drug, in treating meningioma tumors that cannot be removed by surgery and have worsened after radiation therapy. The study focuses on patients with different grades of meningioma to see if Lutathera can help control the disease.

Patient Parameters

Program Overview

This study is exploring how well Lutathera, a radioactive drug given through a vein, works in treating meningioma tumors that cannot be surgically removed and have progressed after radiation therapy. The goal is to determine if Lutathera is safe and effective for patients with these types of tumors, specifically looking at different grades of meningioma.

Description

The main goals of this study are to see how effective Lutathera is in stopping the growth of meningioma tumors for at least six months in patients with different grades of the disease. Researchers will also look at how long patients live after receiving Lutathera and how long they can go without the disease getting worse. Additionally, the study will assess any side effects of the treatment.

Researchers will also study how the treatment affects patients' quality of life and compare different imaging methods to see how well they show the tumor's response to treatment. They will also analyze how much radiation is delivered to the tumor and other organs during treatment.

Participants will receive Lutathera through an IV every eight weeks for up to four cycles, as long as the disease does not progress and side effects are manageable. Before and during treatment, patients will undergo various scans and tests to monitor their health and the tumor's response. After completing the treatment, patients will have follow-up visits every three months for two years, then every six months for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Have previously received treatment for meningioma, including surgery and radiation therapy, if possible.
  • Show evidence of the tumor growing or spreading, with measurable disease on scans.
  • Have previously received radiation therapy at the site of the tumor, with no safe option for more radiation.
  • Be willing to undergo specific PET imaging to assess the tumor.
  • Have a performance status score of 2 or less, indicating they are able to carry out daily activities with some limitations.
  • Meet specific blood count and organ function requirements based on recent tests.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective contraception.
  • Be able to complete questionnaires about their health and quality of life.
  • Provide written informed consent and agree to return for follow-up visits.
  • Agree to participate in a related study on radiotherapy outcomes and biobanking, with optional blood draws.

Exclusion Criteria

  • Be eligible for surgery or radiation with the intent to cure the tumor.
  • Be pregnant, breastfeeding, or unwilling to use contraception if of childbearing potential.
  • Have severe health conditions that would interfere with the study or assessment of the treatment.
  • Be unable to undergo MRI scans.
  • Have a compromised immune system or be HIV positive and on antiretroviral therapy.
  • Have uncontrolled illnesses, such as heart failure, unstable angina, or uncontrolled diabetes.
  • Be receiving other investigational treatments for the tumor.
  • Have had another active cancer within the past two years, except for certain skin or cervical cancers.
  • Have a recent history of heart attack or severe heart failure.
  • Have conditions that make it unsafe to receive Lutathera, such as urinary incontinence or untreated side effects from previous radiation therapy.
  • Have specific types of meningioma, such as optic nerve sheath or extracranial meningioma.

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