Study on Stereotactic Radiosurgery and Immunotherapy (Pembrolizumab) for Treating Recurrent Meningioma

Sponsor: Nancy Ann Oberheim Bush, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04659811

Provider View

This clinical trial is exploring the use of a precise radiation treatment combined with the immunotherapy drug pembrolizumab to treat meningioma that has returned after previous treatments. The study aims to see if this combination can help control the tumor's growth and improve patient outcomes.

Patient Parameters

Program Overview

This study is investigating the effects of combining stereotactic radiosurgery, a precise form of radiation therapy, with pembrolizumab, an immunotherapy drug, in patients with recurrent meningioma. Stereotactic radiosurgery targets brain tumors with high precision, while pembrolizumab helps the immune system recognize and attack cancer cells. The goal is to see if this combination can improve the time patients remain free from disease progression.

Description

The main goal of this study is to determine if the combination of stereotactic radiosurgery and pembrolizumab is effective in treating recurrent meningioma by comparing it to past treatments. Researchers will also look at overall survival rates and how long patients remain free from disease progression.

The study will explore how pembrolizumab affects the tumor using MRI scans and specific assessment criteria. It will also evaluate patients' cognitive function and quality of life during treatment. Safety will be monitored by checking for any serious side effects.

Participants will receive pembrolizumab through an IV on specific days, and stereotactic radiosurgery will be performed at the start of the treatment cycle. If the disease progresses, patients may be eligible for additional cycles of pembrolizumab.

After completing the treatment, patients will have follow-up visits to monitor their health and the treatment's effects for up to five years.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of grade II or III meningioma that has returned or progressed after surgery and radiation.
  • Must be suitable for radiation therapy, with specific size limits for the tumor.
  • No limit on previous surgeries or treatments, but must have recovered from any prior treatments.
  • Must be 18 years or older.
  • Must have a performance status score of 70 or higher, indicating the ability to carry out daily activities.
  • Must have adequate blood cell counts and organ function based on specific tests.
  • Must not be dependent on certain medications or blood transfusions.
  • Must agree to use contraception during and after the study if of childbearing potential.
  • Must be able to understand and agree to the study requirements, including signing a consent form.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Tumors located in the brainstem or spinal cord, unless stable and not progressing.
  • Known cancer spread outside the central nervous system.
  • Recent bleeding in or around the tumor, unless stable.
  • Previous treatment with certain immunotherapy drugs.
  • Recent live vaccinations.
  • Other active cancers requiring treatment in the past three years.
  • Recent use of immunosuppressive treatments.
  • Severe allergies to pembrolizumab or its components.
  • Active autoimmune diseases requiring treatment in the past two years.
  • History of lung inflammation requiring steroids.
  • Active infections or history of certain viral infections.
  • Known psychiatric or substance abuse issues that could affect participation.

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