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

Pacira

Status and phase: Completed; Phase 4

Conditions: Meningeal Neoplasms

Treatments: Drug: Intrathecal (injected into the spinal fluid) DepoCyt; Drug: Intrathecal methotrexate; Drug: Intrathecal cytarabine (also known as ara-C)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00029523

SKY0101-010

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)