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

NCT00221325 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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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 finished NCT00221325 record still lists

NCT00221325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).

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

NCT00221325 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00221325's enrollment target sits among peer trials

14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00221325, the US trial registry maintained by the National Library of Medicine. NCT00221325 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.