NCT00029523

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

Study Contact:

Study Phase:

PHASE4

Recruitment Status:

COMPLETED

NCT ID:

NCT00029523

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Randomized Clinical Study to Determine the Patient Benefit and Safety of Depocyt (Cytarabine Liposome Injection) for the Treatment of Neoplastic Meningitis

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.

Eligibility

* 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

Disease(s) and\or Condition(s)

Meningeal Neoplasms

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: Intrathecal (injected into the spinal fluid) DepoCyt
- Description:
- Arm Group Labels:
- Type: DRUG
- Name: Intrathecal methotrexate
- Description:
- Arm Group Labels:
- Type: DRUG
- Name: Intrathecal cytarabine (also known as ara-C)
- Description:
- Arm Group Labels:

Sponsor

Pacira Pharmaceuticals, Inc