Clinical trial · Interventional
A Safety Study of Rituximab Plus MTX Injected Into the Cerebrospinal Fluid in the Treatment of Brain Lymphoma
Phase I Study of Intraventricular Administration of Rituximab in Combination With Methotrexate in the Treatment of Recurrent CNS and Intraocular Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Nervous System Lymphoma | Central Nervous System Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Intraocular Lymphoma | Primary Intraocular Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraventricular Rituximab Plus MTX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab Plus MTX
- interventionNames
- Drug: Intraventricular Rituximab Plus MTX
Primary outcomes (1)
- measure
- whether intra-CSF administration of rituximab in combination with MTX in patients with recurrent CNS and intraocular lymphoma is associated with neurotoxicity
- timeFrame
- 4 weeks
Secondary outcomes (1)
- measure
- To define the rate of tumor response (CR plus PR) in the brain, spine, eye, or CSF.
- timeFrame
- 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. -
References
Publications (1)
- DERIVEDRubenstein JL, Li J, Chen L, Advani R, Drappatz J, Gerstner E, Batchelor T, Krouwer H, Hwang J, Auerback G, Kadoch C, Lowell C, Munster P, Cha S, Shuman MA, Damon LE. Multicenter phase 1 trial of intraventricular immunochemotherapy in recurrent CNS lymphoma. Blood. 2013 Jan 31;121(5):745-51. doi: 10.1182/blood-2012-07-440974. Epub 2012 Nov 29. PMID 23197589