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TERMINATED
NCT03173950
PHASE2

Immune Checkpoint Inhibitor Nivolumab in People With Recurrent Select Rare CNS Cancers

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

Background: More than 130 primary tumors of the central nervous system (CNS) have been identified. Most affect less than 1,000 people in the United States each year. Because these tumors are so rare, there are few proven therapies. This study will test whether the immunotherapy drug nivolumab is an effective treatment for people with rare CNS tumors. Objectives: To learn if stimulating the immune system using the drug nivolumab can shrink tumors in people with rare CNS (brain or spine) tumors or increase the time it takes for these tumors to grow or spread. Eligibility: Adults whose rare CNS tumor has returned. Design: Individuals will be screened: * Heart and blood tests * Physical and neurological exam * Hepatitis tests * Pregnancy test * Magnetic resonance imaging (MRI). They will lay in a machine that takes pictures. * Tumor tissue sample. This can be from a previous procedure. At the start of the study, participants will have blood tests. They will answer questions about their symptoms and their quality of life. Individuals will get nivolumab in a vein every 2 weeks for up to 64 weeks. Individuals will have monthly blood tests. Every other month they will have an MRI and a neurologic function test. They will also answer questions about their quality of life. Genetic tests will be done on individuals' tumor tissue. Individuals will be contacted if any clinically important results are found. After treatment ends, individuals will be monitored for up to 5 years. They will have a series of MRIs and neurological function tests. They will be asked to report any symptoms they experience....

Official title: Phase II Trial of the Immune Checkpoint Inhibitor Nivolumab in Patients With Recurrent Select Rare CNS Cancers

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2017-07-13

Completion Date

2025-06-23

Last Updated

2026-08-18

Healthy Volunteers

No

Interventions

DRUG

Nivolumab

Individuals will receive nivolumab at standard dose of 240 mg intravenous (IV) every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses.

DIAGNOSTIC_TEST

EKG

Screening/baseline.

DIAGNOSTIC_TEST

MRI Brain and/or spine

Screening/baseline.

DIAGNOSTIC_TEST

Body CT Scan

Screening/baseline.

OTHER

MDASI-BT

Screening/baseline. During active treatment and post therapy follow up.

OTHER

MDASI-SP

Screening/baseline. During active treatment and post therapy follow up.

Locations (3)

Northwestern University

Chicago, Illinois, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

UT MD Anderson Cancer Center

Houston, Texas, United States