A Safety Study of Rituximab Plus MTX Injected Into the Cerebrospinal Fluid in the Treatment of Brain Lymphoma - NCT00221325-94143 (Clinical Trial 130866)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy130866.aspx
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| City: |
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San Francisco |
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State:
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CA |
| Zip Code: |
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94143 |
| Conditions: |
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Central Nervous System Lymphoma - Intraocular Lymphoma |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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. - |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 3, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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