Study on Nivolumab for Treating Recurrent Rare Brain and Spine Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03173950

Provider View

This clinical trial is testing the immunotherapy drug nivolumab to see if it can help shrink tumors or slow their growth in adults with rare brain or spine cancers that have returned after treatment.

Patient Parameters

Program Overview

This study is exploring whether the drug nivolumab can help the immune system fight rare tumors in the brain or spine that have come back after treatment. The main goal is to see if nivolumab can shrink these tumors or delay their growth. Participants will receive the drug through a vein every two weeks for up to 64 weeks. They will have regular check-ups, including blood tests and MRIs, to monitor their health and the tumor's response to the treatment. The study will also look at the impact of the treatment on participants' quality of life.

Description

This study focuses on rare brain and spine tumors that affect fewer than 1,000 people in the U.S. each year. Because these tumors are so rare, there are limited proven treatments available. This trial aims to test the effectiveness of nivolumab, an immunotherapy drug, in treating these tumors when they return after initial treatment.

Participants will undergo a series of tests to ensure they are eligible, including heart and blood tests, physical and neurological exams, and MRIs. They will receive nivolumab every two weeks for up to 64 weeks. Throughout the study, participants will have regular blood tests, MRIs, and assessments of their neurological function and quality of life.

The study will also involve genetic testing of tumor tissue to identify any important findings. After completing the treatment, participants will be monitored for up to five years with regular MRIs and neurological tests to track their progress and any symptoms they experience.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with a rare brain or spine tumor that has returned.
  • Tumor types include Ependymoma, Medulloblastoma, Pineal Region Tumors, Choroid Plexus Tumors, Histone Mutated Gliomas, and others.
  • Must have tumor tissue available for testing.
  • Must have received standard treatments for their tumor and have progressive disease.
  • Good overall health with a performance status of 70 or higher.
  • Adequate blood, kidney, and liver function based on specific tests.
  • No active hepatitis infections.
  • Not taking high doses of corticosteroids.
  • Women of childbearing potential must use effective contraception during and after the study.

Exclusion Criteria

  • Currently receiving other investigational treatments.
  • Previous use of certain immunotherapies or vaccines.
  • Other active or recent cancers that could interfere with the study.
  • Severe heart conditions or recent heart attacks.
  • Recent strokes or serious vascular diseases.
  • Active infections requiring treatment.
  • Severe lung diseases or liver problems.
  • Autoimmune diseases that could worsen with treatment.
  • Pregnant or breastfeeding women.
  • Severe allergies to monoclonal antibodies.
  • Unable to undergo MRI scans.

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