Meningeal Neoplasms
Conditions
Keywords
neoplastic, meningitis, cerebrospinal fluid, CSF, meningeal, meninges, CNS, Leptomeningeal Neoplasms
Brief summary
The purpose of this study is to find out how well an experimental drug called DepoCyt works for neoplastic meningitis (cancer that has spread to the tissues around the brain and spinal cord). DepoCyt is a new slow-release form of the cancer drug called ara-C (cytarabine). Cytarabine has been used for many years to treat cancer.
Interventions
DRUGIntrathecal (injected into the spinal fluid) DepoCyt
DRUGIntrathecal cytarabine (also known as ara-C)
Sponsors
Pacira Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed (or previously diagnosed) with lymphoma or a solid tumor (not leukemia) * Diagnosed with neoplastic meningitis * If female, not pregnant and will not become pregnant while on-study * No other experimental therapy within 21 days of participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, defined as the time to neurological progression or death | — |
Secondary
| Measure | Time frame |
|---|---|
| Karnofsky Performance Scores (KPS) | — |
| Quality of life | — |
| Cytological response rate | — |
| Frequency of improvement in pre-existing meningeal-disease related neurological deficits | — |
| Survival (all-cause and meningeal disease-specific) | — |
| Time to neurological progression; | — |
| Overall safety profile | — |
Countries
Canada, United States
Outcome results
None listed