DepoCyt Therapy in Patients With Neoplastic Meningitis From Lymphoma or a Solid Tumor

Pacira Pharmaceuticals, Inc100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Meningeal Neoplasms

Interventions

Intrathecal (injected into the spinal fluid) DepoCytDRUG

Intrathecal methotrexateDRUG

Intrathecal cytarabine (also known as ara-C)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* 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

Locations (23)

Outcomes

Primary Outcomes

Progression-free survival, defined as the time to neurological progression or death

Secondary Outcomes

Time to neurological progression;

Survival (all-cause and meningeal disease-specific)

Frequency of improvement in pre-existing meningeal-disease related neurological deficits

Karnofsky Performance Scores (KPS)

Quality of life

Cytological response rate

Overall safety profile

Data from ClinicalTrials.gov

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