Clinical trial · Interventional
Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
Phase I/II Study Of Pre-Irradiation Chemotherapy With Methotrexate, Rituximab, And Temozolomide And Post -Irradiation Temozolomide For Primary Central Nervous System 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: Drugs used in chemotherapy such as methotrexate and temozolomide use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining methotrexate, temozolomide, and rituximab with radiation therapy may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide when given together with methotrexate and rituximab followed by radiation therapy and to see how well they work in treating patients with primary central nervous system 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 |
|---|---|---|---|
| methotrexate | Drug | Methotrexate | ALIAS |
| post-radiation therapy temozolomide | Drug | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| rituximab | Drug | Rituximab | ALIAS |
| temozolomide 100 mg/m^2 | Drug | — | UNRESOLVED |
| temozolomide 150 mg/m^2 | Drug | — | UNRESOLVED |
| temozolomide 200 mg/m^2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase I: Temozolomide 100 mg
- description
- Rituximab, methotrexate, temozolomide 100 mg/m\^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m\^2.
- interventionNames
- Drug: rituximab
- Drug: methotrexate
- Drug: temozolomide 100 mg/m^2
- Radiation: radiation therapy
- Drug: post-radiation therapy temozolomide
- type
- EXPERIMENTAL
- label
- Phase I: Temozolomide 150 mg
- description
- Rituximab, methotrexate, temozolomide 150 mg/m\^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m\^2.
- interventionNames
- Drug: rituximab
- Drug: methotrexate
- Drug: temozolomide 150 mg/m^2
- Radiation: radiation therapy
- Drug: post-radiation therapy temozolomide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. Primary central nervous system (CNS) lymphoma \[B-cell, Cluster of Differentiation 20 (CD20) antigen positive\] based on positive biopsy or cerebrospinal fluid (CSF) or vitreous cytology (in association with measurable intraparenchymal tumor). Cytology must demonstrate lymphoma or have an immunohistochemical diagnosis of malignant lymphocytes with a monoclonal lymphocytic population. 2. Life expectancy ≥ 8 weeks; 3. Zubrod performance status of 0-2; 4. Absolute granulocyte count ≥1500/mm3; platelet count ≥ 100,000/mm3; creatinine clearance ≥ 50, calculated with the Cockcroft-Gault Equation: Cr Clearance = (140-age) x wt (kg)/(Cr\[mg/dl\]x 72); Bilirubin, serum glutamate oxaloacetate transaminase (SGOT), alkaline phosphatase (AST) ≤ 2 x institutional upper limits of normal; 5. Patients must sign a study-specific informed consent prior to study entry. 6. Age ≥ 18 Exclusion criteria: 1. Evidence of systemic lymphoma; 2. Prior malignancy (excluding in situ carcinoma of the cervix or non-melanomatous skin cancer)unless disease free for at least five years; 3. Prior radiotherapy to the brain or head/neck; 4. Prior chemotherapy; 5. History of idiopathic sensitivity to any of the drugs to be used; 6. Active infectious process; 7. Seropositive for HIV, AIDS, or post-organ transplant; 8. Pregnant women are ineligible as treatment involves unforeseeable risks to the participant and to the embryo or fetus. 9. Active hepatitis B.
References
Publications (1)
- RESULTGlass J, Won M, Schultz CJ, Brat D, Bartlett NL, Suh JH, Werner-Wasik M, Fisher BJ, Liepman MK, Augspurger M, Bokstein F, Bovi JA, Solhjem MC, Mehta MP. Phase I and II Study of Induction Chemotherapy With Methotrexate, Rituximab, and Temozolomide, Followed By Whole-Brain Radiotherapy and Postirradiation Temozolomide for Primary CNS Lymphoma: NRG Oncology RTOG 0227. J Clin Oncol. 2016 May 10;34(14):1620-5. doi: 10.1200/JCO.2015.64.8634. Epub 2016 Mar 28. PMID 27022122