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NCT00221325 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target

NCT00221325 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 14 participants.

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The verdict

NCT00221325, a Phase 1 study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Intraventricular Rituximab Plus MTX

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2007-04
Est. Completion 2013-03
Phase Phase 1

What the Registry Record Tells You About NCT00221325

The ClinicalTrials.gov registry entry for NCT00221325 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Intraventricular Rituximab Plus MTX is the first listed.

NCT00221325 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00221325 about?

NCT00221325 is a clinical study titled "A Safety Study of Rituximab Plus MTX Injected Into the Cerebrospinal Fluid in the Treatment of Brain Lymphoma". 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 Ritux...

What is the current status of trial NCT00221325?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2007-04. Estimated completion is 2013-03.

What interventions are being tested in trial NCT00221325?

The interventions under investigation include: Intraventricular Rituximab Plus MTX (DRUG).

Who is sponsoring clinical trial NCT00221325?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.