Intrathecal Rituximab in Lymphoid Malignancies Involving Central Nervous System
This study is currently recruiting participants.
Verified February 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01596127
First received: May 8, 2012
Last updated: February 22, 2013
Last verified: February 2013
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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) [ 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).
| 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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 3 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have relapsed or refractory CD20+ lymphoid malignancies with either documented Central Nervous System (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. (Eastern Cooperative Oncology Group (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
Exclusion Criteria:
- Known active meningeal infection
- History of severe infusion reaction to any monoclonal antibody
- Patients with prior neuraxis radiotherapy are excluded.
- Patients are excluded for any prior history of whole-brain or cranio-spinal irradiation or any current need for whole-brain or cranio-spinal irradiation. A need for focused radiation therapy to a portion of the spine will not make patients ineligible.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596127
Contacts
| Contact: Elias Jabbour, MD | 713-792-4764 |
Locations
| United States, Texas | |
| UT 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 | UT MD 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 |
| Study First Received: | May 8, 2012 |
| Last Updated: | February 22, 2013 |
| 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:
|
Neoplasms Leukemia Meningeal Carcinomatosis Neoplasms, Second Primary Neoplasms by Histologic Type Meningeal Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site |
Nervous System Diseases Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013