Clinical trial · Interventional
Intrathecal Rituximab in Treating Patients With Recurrent CNS Lymphoma
Phase I Study of Intrathecal Rituximab in Patients With Recurrent CNS 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)
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab intrathecally may be an effective treatment for recurrent CNS lymphoma. PURPOSE: This phase I trial is studying the side effects and best dose of intrathecal rituximab in treating patients with recurrent CNS 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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- intrathecal rituximab
- description
- 3 dose levels of intrathecal rituximab, 10mg, 25mg, 50mg
- interventionNames
- Biological: rituximab
Primary outcomes (3)
- measure
- Adverse events as a measure of safety of intrathecal administration of Rituximab
- timeFrame
- up to 5 years after completion of 5 week study treatment
- measure
- Serum concentration of Rituximab
- timeFrame
- during 5 weeks of study treatment
- measure
- Cerebrospinal Fluid (CSF) concentration of Rituximab
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Cytologically confirmed relapsed CNS lymphoma * Arising from primary CNS lymphoma or systemic non-Hodgkin's lymphoma * Evidence of brain parenchymal involvement, cerebrospinal fluid (CSF) involvement, or ocular involvement after radiation treatment or intrathecal chemotherapy * Tumors must be CD20+ on pathologic analysis * Refractory or persistent disease allowed * No complete obstruction of the CSF pathway within the ventricular system unless alleviated by external beam radiotherapy or systemic chemotherapy * No obstructive hydrocephalus PATIENT CHARACTERISTICS: * Karnofsky performance status \> 50% * Must have an Ommaya reservoir * Granulocyte count \> 1,500/mm\^3 * Platelet count \> 50,000/mm\^3 * Anticipated survival ≥ 1 month PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from toxicity of prior therapy * Prior intrathecal methotrexate, cytarabine, or thiotepa for CNS lymphoma allowed * Concurrent systemic chemotherapy for treatment of disease outside meninges allowed except for high-dose methotrexate, high-dose cytarabine, high-dose thiotepa, or investigational agents * No history of whole-brain or craniospinal radiation \< 1 week before study entry * No history of intrathecal chemotherapy \< 1 week before study entry * No concurrent intrathecal chemotherapy
References
Publications (1)
- RESULTRubenstein JL, Fridlyand J, Abrey L, Shen A, Karch J, Wang E, Issa S, Damon L, Prados M, McDermott M, O'Brien J, Haqq C, Shuman M. Phase I study of intraventricular administration of rituximab in patients with recurrent CNS and intraocular lymphoma. J Clin Oncol. 2007 Apr 10;25(11):1350-6. doi: 10.1200/JCO.2006.09.7311. Epub 2007 Feb 20. PMID 17312328