Intrathecal Rituximab in Lymphoid Malignancies Involving Central Nervous System

NCT01596127 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 2011-0844NCI-2012-00849
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leukemia; Lymphoid Malignancies; Metastatic Malignant Neoplasm to the Leptomeninges

Keywords

relapsed CD20+ lymphoid malignancies; refractory CD20+ lymphoid malignancies; Rituximab; Intrathecal Rituximab; CNS; Leptomeningeal disease; LMD; central nervous system disease; Relapsed lymphoid malignancies; refractory lymphoid malignancies; CNS leukemia; intrathecal chemotherapy; cerebrospinal fluid; CSF; lumbar puncture; LP

Outcome Measures

Primary Outcomes (1)

• Response Rate

  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.

  2 weeks

Secondary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Rituximab

  2 weeks

Study Arms (1)

Intrathecal Rituximab

EXPERIMENTAL

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

Interventions

Intrathecal Rituximab DRUG

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.

Also known as: Rituxan

Intrathecal Rituximab

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have relapsed or refractory CD20+ lymphoid malignancies with either documented CNS involvement or peripheral nerve infiltration.
• 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.
• ECOG performance status measure will be used. (ECOG Performance Status less than or equal to 3)
• Adequate liver function (bilirubin less than or equal to 3 mg/dL within 24 hours of enrollment)
• Adequate renal function (serum creatinine less than or equal to 3 mg/dL within 24 hours of enrollment)
• 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.
• Signed informed consent

You may not qualify if:

• Known active meningeal infection
• History of severe infusion reaction to any monoclonal antibody

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia; Meningeal Carcinomatosis; Meningeal Neoplasms; Central Nervous System Diseases

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Elias Jabbour MD/Associate Professor
• Organization: The University of Texas MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-7734

Study Officials

• Elias Jabbour, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 10, 2012
• Study Start: January 24, 2013
• Primary Completion: March 23, 2017
• Study Completion: March 23, 2017
• Last Updated: May 24, 2018
• Results First Posted: March 27, 2018

Record last verified: 2018-04

Locations

US (1)