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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT03173950
Phase
PHASE2
Status
Completed

Conditions

  • Atypical/Malignant Meningioma
  • Choroid Plexus Tumors
  • Ependymoma
  • Medulloblastoma
  • Pineal Region Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Individuals will receive nivolumab at standard dose of 240 mg IV every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses

Study Details

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 * 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....

Key Dates

Start date
Jul 13, 2017
Status verified
Jun 2025
Primary completion
Jun 23, 2025
Completion
Jun 23, 2025

Study Design

Enrollment
133 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1/Experimental Therapy
    Individuals will receive nivolumab at standard dose of 240 mg IV every 2 weeks for cycles 1 through 2, then doses of 480 mg every 4 weeks for a total of 14 additional doses

Primary Outcome Measure

objective response [ Time Frame: end of treatment ]

Locations (3)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
UT MD Anderson Cancer CenterHoustonTexas77030-4096-

Find similar trials in Chicago, IL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Northwestern University· Chicago, ILNational Institutes of Health Clinical Center· Bethesda, MDUT MD Anderson Cancer Center· Houston, TX

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