Phase I/Ib Study of Concurrent Intravenous and Intrathecal Nivolumab for Melanoma and Lung Cancer Patients With Leptomeningeal Disease (LMD)
M.D. Anderson Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. To determine the safety and/or recommended dose of intrathecal (IT) nivolumab in combination with systemic nivolumab treatment in melanoma and lung cancer with leptomeningeal disease (LMD). SECONDARY OBJECTIVE: I. To assess overall survival with combined intrathecal and systemic administration of nivolumab in this patient population. EXPLORATORY OBJECTIVES: I. Compare the immunological effects of this treatment on immune cells in the cerebrospinal fluid (CSF) to those observed in the peripheral blood and in non-LMD tumors. II. Evaluation of predictors (clinical, mol…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have radiographic and/or CSF cytological evidence of LMD. For patient with melanoma: Must have a confirmed diagnosis of primary central nervous system (CNS) melanoma, melanocytomas or metastatic melanoma (cutaneous, acral-lentiginous, uveal and mucosal in origin), based on histological analysis of metastatic tissue and/or cancer cells, archival tissue permitted. For patients with lung cancer: non-small cell, based on histological analysis of metastatic tissue and/or cancer cells, archival tissue permitted * Patients must have an Eastern Cooperative Oncology…
Interventions
- ProcedureBiospecimen Collection
Correlative studies
- ProcedureComputed Tomography
Undergo CT
- ProcedureLumbar Puncture
Undergo lumbar puncture for cerebrospinal fluid collection
- ProcedureMagnetic Resonance Imaging
Undergo MRI of brain and spine
- BiologicalNivolumab
Given IV or IT
- ProcedurePositron Emission Tomography
Undergo PET
Location
- M D Anderson Cancer CenterHouston, Texas