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Intrathecal Rituximab in Lymphoid Malignancies Involving Central Nervous System

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01596127
First received: May 8, 2012
Last updated: October 31, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoid Malignancies
Metastatic Malignant Neoplasm to the Leptomeninges
Drug: Intrathecal Rituximab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Intrathecal Rituximab in Patients With Lymphoid Malignancies Involving the Central Nervous System

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: Response assessed after minimum 2 weeks/4 treatments (2 twice weekly treatments) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of Rituximab [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 25
Study Start Date: January 2013
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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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  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01596127

Contacts
Contact: Elias Jabbour, MD 713-792-4764

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Elias Jabbour, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Elias Jabbour, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01596127     History of Changes
Other Study ID Numbers: 2011-0844, NCI-2012-00849
Study First Received: May 8, 2012
Last Updated: October 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Leukemia
Meningeal Carcinomatosis
Neoplasms
Neoplasms, Second Primary
Central Nervous System Neoplasms
Meningeal Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014