Pemetrexed and Temozolomide in Treating Patients With Relapsed Primary Central Nervous System Lymphoma （PCNSL）

• Status: Unknown status
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rongjie Tao
• Collaborator: National Natural Science Foundation of China
• Treatments: Dacarbazine; Pemetrexed; Temozolomide

Criteria

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
• 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.