Clinical trial · Interventional
Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
Intensive Chemotherapy and Immunotherapy in Patients With Newly Diagnosed Primary CNS Lymphoma: A Pilot Study
- 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: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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 together with combination chemotherapy may kill more cancer cells. PURPOSE: This clinical trial is studying the side effects and best ways to give combination chemotherapy together with rituximab in treating patients with newly diagnosed primary 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 | Central Nervous System Neoplasm | PROBABILISTIC | 0.70 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| etoposide phosphate | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| rituximab | Biological | Rituximab | ALIAS |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- methotrexate, leucovorin calcium, rituximab, and temozolomide
- description
- Determine the rate of toxicity, in terms of percentage of patients with grade 4 neurotoxicity, in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate.
- interventionNames
- Biological: filgrastim
- Biological: rituximab
- Drug: cytarabine
- Drug: etoposide phosphate
- Drug: leucovorin calcium
- Drug: methotrexate
- Drug: temozolomide
Primary outcomes (1)
- measure
- rate of toxicity in patients with untreated primary CNS lymphoma
- timeFrame
- up to 8 months
- description
- Determine the rate of toxicity, in terms of percentage of patients with grade 4 neurotoxicity, in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed untreated primary CNS lymphoma (PCNSL) confirmed by 1 of the following methods:
* Brain biopsy or resection
* Patients diagnosed with T-cell PCNSL allowed but will not receive rituximab on study
* Cerebrospinal fluid (CSF) cytology
* Positive CSF cytology with or without measurable intracranial disease
* Vitreal biopsy
* Histologic confirmation of vitreal lymphoma with measurable intracranial tumor
* No evidence of systemic non-Hodgkin's lymphoma
* CT scan of chest, abdomen, and pelvis or bone marrow biopsy negative for extracerebral source of lymphoma
* No evidence of pleural effusions or ascites
* MRI of brain and spine (plus gadolinium) must have measurable contrast enhancing disease unless CSF cytology is positive
PATIENT CHARACTERISTICS:
* Karnofsky performance score 50-100%
* HIV negative
* Creatinine clearance ≥ 50 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* No concurrent salicylates, nonsteroidal anti-inflammatory drugs, sulfonamides, or penicillins within the past weekReferences
Publications (1)
- RESULTWieduwilt MJ, Valles F, Issa S, Behler CM, Hwang J, McDermott M, Treseler P, O'Brien J, Shuman MA, Cha S, Damon LE, Rubenstein JL. Immunochemotherapy with intensive consolidation for primary CNS lymphoma: a pilot study and prognostic assessment by diffusion-weighted MRI. Clin Cancer Res. 2012 Feb 15;18(4):1146-55. doi: 10.1158/1078-0432.CCR-11-0625. Epub 2012 Jan 6. PMID 22228634