Clinical Trial: A Safety Study of Rituximab Plus MTX Injected Into the Cerebrospinal Fluid in the Treatment of Brain Lymphoma

This study is not yet open for patient recruitment.
Verified by University of California, San Francisco January 2005

Sponsored by: University of California, San Francisco
Information provided by: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00221325

Purpose

Rituximab is the first monoclonal antibody to receive approval in the treatment of cancer and has been proven to lead to extended survival when administered intravenously in the treatment of patients with systemic non-Hodgkin''''s lymphoma. We have previously demonstrated that a small fraction of Rituximab administered intravenously is able to cross the blood-brain-barrier into the brain.

We will test the idea that the direct injection into the cerebrospinal fluid of Rituximab, a monoclonal antibody which attacks and kills lymphoma cells, is safe and when used in combination with methotrexate in patients with recurrent brain and intraocular lymphoma.

We will also test the idea that the combination of rituximab plus methotrexate has activity and is effective in the treatment of recurrent brain and intraocular lymphoma.

Condition Intervention Phase
Central nervous system lymphoma
Intraocular Lymphoma
 Drug: Intraventricular Rituximab Plus MTX
Phase I

MedlinePlus related topics:  Eye Cancer;   Lymphoma

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study

Official Title: Phase I Study of Intraventricular Administration of Rituximab in Combination with Methotrexate in the Treatment of Recurrent CNS and Intraocular Lymphoma

Further Study Details: 

Expected Total Enrollment:  20

Rituximab is the first monoclonal antibody to receive FDA approval in the treatment of cancer. Intravenous administration of rituximab has been demonstrated to lead to prolongation of survival when used in combination with chemotherapy in the treatment of patients with systemic non-Hodgkin''''s lymphoma. We have previously demonstrated that a small fraction of Rituximab administered intravenously is able to cross the blood-brain-barrier into the brain and we have also previously demonstrated that direct intraventricular administration of Rituximab is able to achieve high concentrations within the cerebrospinal fluid ventricles and lumbar sac.

We will test the hypothesis that the direct intraventricular injection of Rituximab in combination with Methotrexate is safe and when used in combination in patients with recurrent brain and intraocular lymphoma. We will evaluate the safety of this combination by testing different dose levels of Rituximab. We will also measure the concentration of Rituximab in the intraocular compartments and cerebrospinal fluid at different time points after intraventricular administration to determine the pharmacokinetics of intrathecal Rituximab as well as the potential impact of Methotrexate on Rituximab distribution.

We will also test the hypothesis that the intraventricular administration of the combination of rituximab plus methotrexate has activity and is effective in the treatment of recurrent brain and intraocular lymphoma.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  1. Relapsed, refractory CNS lymphoma, ocular lymphoma, lymphomatous meningitis
  2. Tumors must be CD20 + on pathologic analysis.
  3. Patients must have an Ommaya reservoir (ventricular access device.
  4. Patients may have had prior intrathecal methotrexate, ara-C or thiotepa but must have recovered from any reversible toxicity caused by prior treatment.
  5. Concurrent systemic chemotherapy is allowed for treatment of disease outside the meninges with the exception of high-dose methotrexate (>500 mg/m2/d, high-dose ara-C (> 2 gm/m2/d), high-dose thiotepa (>300 mg/m2/d) or investigational agents.
  6. Patients must have sufficient baseline hematologic function: >1,500 granulocytes and >50,000 platelets/ul.
  7. Patients must have had a nuclear medicine CSF flow study performed within 30 days of treatment which shows no significant obstruction within the ventricles.

Exclusion Criteria:

  1. History of whole brain or craniospinal irradiation or intrathecal chemotherapy < 4 days before initiation of intra-CSF administration of rituximab.
  2. Anticipated survival of less than one month.
  3. HIV infection. -

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00221325

James L. Rubenstein, MD, PhD      415-502-4430    jamesr@medicine.ucsf.edu

California
      University of California, San Francisco, San Francisco,  California,  94143,  United States
James L Rubenstein, MD, PhD  415-502-4430    jamesr@medicine.ucsf.edu 

      Stanford University Medical Center, Stanford,  California,  94123,  United States
Ranjana Advani, MD
Ronald Levy, MD

      University of Southern California, Los Angeles,  California,  United States

Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  United States
Tracy Batchelor, MD

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  94123,  United States
Lauren Abrey, MD

Texas
      MD Anderson Cancer Center, Houston,  Texas,  United States

Study chairs or principal investigators

James L. Rubenstein, MD PhD,  Study Chair,  University of California, San Francisco   

More Information

Study ID Numbers:  CC06254; Pending
Last Updated:  September 21, 2005
Record first received:  September 14, 2005
ClinicalTrials.gov Identifier:  NCT00221325
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-27

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