Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease

This phase I/Ib trial studies the side effects and best dose of intrathecal nivolumab, and how well it works in combination with intravenous nivolumab in treating patients with leptomeningeal disease. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Trial Details

NCT ID
NCT03025256
Phase
PHASE1
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Biospecimen Collection
  • Computed Tomography
  • Lumbar Puncture
  • Magnetic Resonance Imaging
  • Nivolumab
  • Positron Emission Tomography
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Patients must have radiographic and/or CSF cytological evidence of LMD. For patient with melanoma: Must have a confirmed diagnosis of primary centr…
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of =\< 2
  • Patients may receive steroids to control symptoms related to CNS involvement, but the dose must be =\< 4 mg per 24 hours of dexamethasone (or the e…
  • Patients who have received radiation to brain and/or spine, including whole brain radiation, stereotactic radiosurgery, or stereotactic body radiat…

For full eligibility, visit ClinicalTrials.gov.

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