Intrathecal Rituximab in Lymphoid Malignancies Involving Central Nervous System

• Status: Terminated
• Trial end date: 2017-03-23
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to learn about the safety and effectiveness of rituximab given by spinal tap in patients with lymphoid malignancies involving the central nervous system.

A spinal tap (also called a lumbar puncture) is when fluid surrounding the spinal cord is collected by inserting a needle into the lower back. The affected area is numbed with local anesthetic during the procedure. It will also be used to give chemotherapy in this study.

Rituximab is designed to bind to a protein, called CD20, that is on the surface of the leukemia cells. This may cause the leukemia cells to die.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Rituximab

Criteria

Inclusion Criteria:

1. Patients must have relapsed or refractory CD20+ lymphoid malignancies with either documented CNS involvement or peripheral nerve infiltration.

2. Patients 3 years of age and older are eligible after 3 patients (age 15 or older) have been treated and did not experience a dose limiting toxicity. Patient 3 to 15 years of age will follow the dose escalation schema independent of the adults.

3. ECOG performance status measure will be used. (ECOG Performance Status less than or equal to 3)

4. Adequate liver function (bilirubin less than or equal to 3 mg/dL within 24 hours of enrollment)

5. Adequate renal function (serum creatinine less than or equal to 3 mg/dL within 24 hours of enrollment)

6. Urine pregnancy test for women of childbearing potential (defined as not post-menopausal for 12 consecutive months or no previous surgical sterilizations). A negative urine pregnancy test is required within 48 hours of initiating study drug.

7. Signed informed consent

Exclusion Criteria:

1. Known active meningeal infection

2. History of severe infusion reaction to any monoclonal antibody