Clinical trial · Interventional
Pemetrexed and Temozolomide in Treating Patients With Relapsed Primary Central Nervous System Lymphoma (PCNSL)
Phase II Trial of Pemetrexed and Temozolomide in Treating Patients With Relapsed PCNSL
NCT01985451CI-TRIAL-00012651unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
In this trial, we will treat relapsed PCNSL with temozolomide, pemetrexed. Our objective was to assess our treatment strategies' availability based on response rates, progression-free survival (PFS), median PFS, and toxicity.
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 |
|---|---|---|---|
| Central Nervous System Tumors | Central Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pemetrexe | Drug | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pemetrexed and Temozolomide
- description
- Patients with relapsed PCNSL patients were treated with high-dose pemetrexed (900mg/m2) and temozolomide (200mg/m² day 1-5, 28 day cycle).
- interventionNames
- Drug: Pemetrexe
- Drug: Temozolomide
Primary outcomes (1)
- measure
- complete response (CR)
- timeFrame
- 2 years
- description
- Contrast MRI was performed to assess treatment response at 3-month interval for 2 years and thereafter every 6 months for next 3-5 years and then annually. The treatment response was reassessed according to International PCNSL Collaborative Group' criteria\[1\]. \[1\] Abrey LE, Batchelor TT, Ferreri AJ, Gospodarowicz M, Pulczynski EJ, Zucca E, et al. Report of an international workshop to standardize baseline evaluation and response criteria for primary CNS lymphoma. International Primary CNS Lymphoma Collaborative Group. J Clin Oncol 2005;23:5034-43.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed primary CNS lymphoma. * ECOG (Eastern Cooperative Oncology Group) Performance status of 0-1. * Positive cerebrospinal fluid (CSF) cytology or immunohistochemical diagnosis of CSF monoclonality with or without measurable intracranial disease. * Measurable (greater than 1 cm in diameter) tumor by CT scan or MRI. * Progressed during first-line chemotherapy and/or radiotherapy OR relapsed after initial successful treatment. * No systemic lymphoma by CT scan of the chest, abdomen, and pelvis with contrast. * No leptomeningeal lymphoma by lumbar puncture for CNS cytology/flow cytometry. * No ocular lymphoma by slit lamp examination. * Must have adequate organ function as defined by the protocol: Adequate renal function: serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 60 ml/min; Adequate hepatic function: bilirubin level ≤ 1.5 x ULN, ASAT \& ALST ≤ 1.5 x ULN.Adequate bone marrow reserves: neutrophil (ANC) count ≥ 1500 /mm\^3, platelet count ≥ 100,000 /mm\^3, hemoglobin ≥ 9 g/dl. * Age \>/= 18 and \</= 75 years. * Signed written informed consent prior to study entry. Exclusion Criteria: * Patients with human immunodeficiency virus seropositivity and systemic lymphoma manifestation. * Serious uncontrolled concurrent illness. * Previous brain radiotherapy, systemic chemotherapy. * Concurrent chronic systemic immune therapy, targeted therapy not indicated in this study protocol. * Any evidence of prior exposure to Hepatitis B virus. * Unable to comprehend the study requirements or who are not likely to comply with the study parameters. * Pregnant (confirmed by serum or urine β-HCG) or lactating.
References
Publications (3)
- RESULTRaizer JJ, Rademaker A, Evens AM, Rice L, Schwartz M, Chandler JP, Getch CC, Tellez C, Grimm SA. Pemetrexed in the treatment of relapsed/refractory primary central nervous system lymphoma. Cancer. 2012 Aug 1;118(15):3743-8. doi: 10.1002/cncr.26709. Epub 2011 Dec 16. PMID 22179954
- RESULTZhang JP, Lee EQ, Nayak L, Doherty L, Kesari S, Muzikansky A, Norden AD, Chen H, Wen PY, Drappatz J. Retrospective study of pemetrexed as salvage therapy for central nervous system lymphoma. J Neurooncol. 2013 Oct;115(1):71-7. doi: 10.1007/s11060-013-1196-1. Epub 2013 Jul 5. PMID 23828279
- RESULTLeshchenko VV, Kuo PY, Jiang Z, Thirukonda VK, Parekh S. Integrative genomic analysis of temozolomide resistance in diffuse large B-cell lymphoma. Clin Cancer Res. 2014 Jan 15;20(2):382-92. doi: 10.1158/1078-0432.CCR-13-0669. Epub 2013 Oct 31. PMID 24178621