Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03025256
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Acral Lentiginous Melanoma
  • Central Nervous System Melanoma
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Leptomeningeal Neoplasm
  • Melanocytoma
  • Metastatic Lung Non-Small Cell Carcinoma
  • Metastatic Melanoma
  • Metastatic Mucosal Melanoma
  • Metastatic Uveal Melanoma
  • Stage IV Lung Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Correlative studies
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Lumbar Puncture — PROCEDURE
    Undergo lumbar puncture for cerebrospinal fluid collection
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI of brain and spine
  • Nivolumab — BIOLOGICAL
    Given IV or IT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET

Study Details

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.

Key Dates

Start date
May 2, 2018
Status verified
Apr 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nivolumab)
    Patients receive nivolumab IT over 5 minutes on day 1 of every cycle. Beginning in cycle 2, patients also receive nivolumab IV over 30 minutes on day 1 (4 hours after the IT dose). Cycles repeat every 14 days for 18 cycles and then every 28 days (cycles 19 and beyond) in the absence of disease progression or unacceptable toxicity. Patients will have CSF and blood specimen collection on days 1, 2, 8 of each cycle and end of treatment. Patients undergo CT or PET at baseline, cycle 5 and then every 8 weeks. Patients undergo MRI at baseline, cycles 3, 5, and then every 8 weeks.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Isabella C. Glitza, MD
[email protected]
713-792-2921
Isabella C. Glitza, MD (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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