Clinical trial · Interventional
Rituximab, Temozolomide, and Methylprednisolone in Treating Patients With Recurrent Primary CNS Non-Hodgkin's Lymphoma
A Phase II Study of Rituximab and Temozolomide in Recurrent Primary CNS Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual/lack of resources/low priority due to combining 2 consortia
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. Drugs used in chemotherapy, such as temozolomide and methylprednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Rituximab may help chemotherapy kill more cancer cells by making cancer cells more sensitive to the drugs. Giving rituximab together with temozolomide and methylprednisolone may be an effective treatment for primary CNS non-Hodgkin's lymphoma. PURPOSE: This phase II trial is studying how well giving rituximab together with temozolomide and methylprednisolone works in treating patients with recurrent primary CNS non-Hodgkin's lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| methylprednisolone | Drug | — | UNRESOLVED |
| rituximab | Biological | Rituximab | ALIAS |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IV Rituximab
- description
- IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks. Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide \[TMZ\] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression
- interventionNames
- Biological: rituximab
- Drug: methylprednisolone
- Drug: temozolomide
Primary outcomes (1)
- measure
- Percentage of Participants With Objective Response
- timeFrame
- 2 months
- description
- Objective response rate of the combination of Rituximab and TMZ
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary CNS non-Hodgkin's lymphoma by brain biopsy, positive cerebrospinal fluid cytology, or vitrectomy * Recurrent disease * Measurable disease, define as bi-dimensionally measurable lesions with clearly defined margins by brain MRI or CT scan * Radiographical evidence of tumor progression by MRI or CT scan * Steroid therapy must be stable for 5 days prior to scan PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * More than 8 weeks Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL (transfusion allowed) Hepatic * SGOT \< 2 times upper limit of normal (ULN) * Bilirubin \< 2 times ULN * No active or latent hepatitis B infection Renal * Creatinine \< 1.5 mg/dL OR * Creatinine clearance ≥ 60 mL/min Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No uncontrolled significant medical illness that would preclude study treatment * No active infection * No active HIV infection * No concurrent disease that would dangerously alter drug metabolism or obscure toxicity PRIOR CONCURRENT THERAPY: Biologic therapy * At least 7 days since prior interferon or thalidomide * No concurrent prophylactic filgrastim (G-CSF) * No concurrent immunotherapy Chemotherapy * No prior temozolomide * At least 14 days since prior methotrexate * At least 21 days since prior procarbazine * At least 42 days since prior nitrosoureas * No other concurrent chemotherapy Endocrine therapy * See Disease Characteristics * At least 7 days since prior tamoxifen * No concurrent hormonal therapy Radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * Recovered from all prior therapy * At least 28 days since prior investigational agents * At least 28 days since other prior cytotoxic therapy * At least 7 days since other prior non-cytotoxic agents (e.g., tretinoin) (radiosenitizers allowed) * No other concurrent investigational drugs
References
Publications (2)
- RESULTNayak L, Abrey LE, Drappatz J, et al.: Multicenter phase II trial of temozolomide (TMZ) and rituximab (RIT) for recurrent primary CNS lymphoma (PCNSL): North American Brain Tumor Consortium (NABTC) study 05-01. [Abstract] J Clin Oncol 29 (Suppl 15): A-2039, 2011.
- DERIVEDNayak L, Abrey LE, Drappatz J, Gilbert MR, Reardon DA, Wen PY, Prados M, Deangelis LM, Omuro A; North American Brain Tumor Consortium. Multicenter phase II study of rituximab and temozolomide in recurrent primary central nervous system lymphoma. Leuk Lymphoma. 2013 Jan;54(1):58-61. doi: 10.3109/10428194.2012.698736. Epub 2012 Jul 9. PMID 22656234