Intrathecal Rituximab in Treating Patients With Recurrent CNS Lymphoma
This study has been completed.
Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00416923
First received: December 27, 2006
Last updated: February 12, 2015
Last verified: February 2015
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Purpose
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab intrathecally may be an effective treatment for recurrent CNS lymphoma.
PURPOSE: This phase I trial is studying the side effects and best dose of intrathecal rituximab in treating patients with recurrent CNS lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Lymphoma |
Biological: rituximab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Intrathecal Rituximab in Patients With Recurrent CNS Lymphoma |
Resource links provided by NLM:
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Rituximab
Genetic and Rare Diseases Information Center resources:
B-cell Lymphomas
Burkitt Lymphoma
Central Nervous System Lymphoma, Primary
Chronic Lymphocytic Leukemia
Follicular Lymphoma
Leukemia, B-cell, Chronic
Lymphoblastic Lymphoma
Lymphoma, Large-cell
Lymphoma, Large-cell, Immunoblastic
Lymphoma, Small Cleaved-cell, Diffuse
Lymphosarcoma
Mantle Cell Lymphoma
Plasmablastic Lymphoma
Small Non-cleaved Cell Lymphoma
Squamous Cell Carcinoma of the Head and Neck
Waldenstrom Macroglobulinemia
U.S. FDA Resources
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- Adverse events as a measure of safety of intrathecal administration of Rituximab [ Time Frame: up to 5 years after completion of 5 week study treatment ] [ Designated as safety issue: Yes ]
- Serum concentration of Rituximab [ Time Frame: during 5 weeks of study treatment ] [ Designated as safety issue: Yes ]
- Cerebrospinal Fluid (CSF) concentration of Rituximab [ Time Frame: during 5 weeks of study treatment ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 10 |
| Study Start Date: | August 2002 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: intrathecal rituximab
3 dose levels of intrathecal rituximab, 10mg, 25mg, 50mg
|
Biological: rituximab |
Detailed Description:
OBJECTIVES:
Primary
- Determine the safety and pharmacokinetics of intrathecal rituximab in patients with recurrent CNS lymphoma arising from CD20+ B-cell non-Hodgkin's lymphoma.
Secondary
- Determine the efficacy of intrathecal rituximab.
- Determine the molecular pathogenesis of lymphomatous meningitis.
- Determine the molecular basis for response or lack of response to rituximab.
- Identify molecular markers specific for lymphomatous meningitis that will be useful for prognostic evaluation of peripheral lymphomas.
- Determine the quality of life of patients treated with intrathecal rituximab.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive rituximab intrathecally over 10 minutes on day 1 in week 1 and on days 1 and 4 in weeks 2-5 in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial response with no rituximab-related neurotoxicity may continue to receive treatment beyond 5 weeks.
Cohorts of patients receive escalating doses of rituximab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which fewer than 1/3 of patients experience dose-limiting toxicity.
Quality of life is assessed at baseline and at the completion of study treatment.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 17 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
-
Cytologically confirmed relapsed CNS lymphoma
- Arising from primary CNS lymphoma or systemic non-Hodgkin's lymphoma
- Evidence of brain parenchymal involvement, cerebrospinal fluid (CSF) involvement, or ocular involvement after radiation treatment or intrathecal chemotherapy
- Tumors must be CD20+ on pathologic analysis
- Refractory or persistent disease allowed
- No complete obstruction of the CSF pathway within the ventricular system unless alleviated by external beam radiotherapy or systemic chemotherapy
- No obstructive hydrocephalus
PATIENT CHARACTERISTICS:
- Karnofsky performance status > 50%
- Must have an Ommaya reservoir
- Granulocyte count > 1,500/mm^3
- Platelet count > 50,000/mm^3
- Anticipated survival ≥ 1 month
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from toxicity of prior therapy
- Prior intrathecal methotrexate, cytarabine, or thiotepa for CNS lymphoma allowed
- Concurrent systemic chemotherapy for treatment of disease outside meninges allowed except for high-dose methotrexate, high-dose cytarabine, high-dose thiotepa, or investigational agents
- No history of whole-brain or craniospinal radiation < 1 week before study entry
- No history of intrathecal chemotherapy < 1 week before study entry
- No concurrent intrathecal chemotherapy
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: NCT00416923
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416923
Sponsors and Collaborators
University of California, San Francisco
Investigators
| Principal Investigator: | James L. Rubenstein, MD, PhD | University of California, San Francisco |
More Information
Additional Information:
Publications:
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00416923 History of Changes |
| Other Study ID Numbers: | CDR0000454842, UCSF-01302, UCSF-H9414-19588-04, UCSF-U2337S, GENENTECH-UCSF-01302 |
| Study First Received: | December 27, 2006 |
| Last Updated: | February 12, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of California, San Francisco:
|
recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma stage IV adult Burkitt lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma |
stage IV adult diffuse small cleaved cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV mantle cell lymphoma stage IV marginal zone lymphoma stage IV small lymphocytic lymphoma primary central nervous system non-Hodgkin lymphoma leptomeningeal metastases intraocular lymphoma AIDS-related primary CNS lymphoma Waldenström macroglobulinemia extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue |
Additional relevant MeSH terms:
|
Central Nervous System Neoplasms Lymphoma Nervous System Neoplasms Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type |
Neoplasms by Site Nervous System Diseases Rituximab Antineoplastic Agents Antirheumatic Agents Immunologic Factors Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015