Intrathecal Rituximab in Lymphoid Malignancies Involving Central Nervous System
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.
|Leukemia Lymphoid Malignancies Metastatic Malignant Neoplasm to the Leptomeninges||Drug: Intrathecal Rituximab||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of Intrathecal Rituximab in Patients With Lymphoid Malignancies Involving the Central Nervous System|
- Response Rate [ Time Frame: Response assessed after minimum 2 weeks/4 treatments (2 twice weekly treatments) ]The percentage of participants whose cancer shrinks or disappears after treatment where participants are considered as responding to therapy if the Cerebrospinal fluid (CSF) is without evidence of blast cells after four lumbar punctures with rituximab.
- Maximum Tolerated Dose (MTD) of Rituximab [ Time Frame: 2 weeks ]MTD is dose level at which at least 1 of 3 participants experiences a dose-limiting toxicity (DLT). DLTdefined as clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and meeting the NCI common terminology criteria that are CTCAE Grade 3 or 4.
|Actual Study Start Date:||January 24, 2013|
|Study Completion Date:||March 23, 2017|
|Primary Completion Date:||March 23, 2017 (Final data collection date for primary outcome measure)|
Experimental: Intrathecal Rituximab
Phase I Starting Dose: Rituximab administered via lumbar puncture at dose of 10 - 25 mg twice weekly according to the dose escalation.
Phase II Rituximab Starting Dose: Maximum tolerated dose from Phase I.
Drug: Intrathecal Rituximab
Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.
Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I.
Other Name: Rituxan
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01596127
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Elias Jabbour, MD||M.D. Anderson Cancer Center|