Overview

This trial is active, not recruiting.

Condition central nervous system tumors
Treatments pemetrexe, temozolomide
Phase phase 2
Sponsor Rongjie Tao
Collaborator National Natural Science Foundation of China
Start date March 2013
End date March 2015
Trial size 15 participants
Trial identifier NCT01985451, ShandongCHI, ShandongCHI002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients with relapsed PCNSL patients were treated with high-dose pemetrexed (900mg/m2) and temozolomide (200mg/m² day 1-5, 28 day cycle).
pemetrexe Alimta
Patients with relapsed PCNSL patients were treated with high-dose pemetrexed (900mg/m²).
temozolomide Temodal
Patients with relapsed PCNSL patients were treated with temozolomide (200mg/m² day 1-5,28).

Primary Outcomes

Measure
complete response (CR)
time frame: 2 years

Secondary Outcomes

Measure
Failure-free survival (PFS)
time frame: 2 years
Toxicity
time frame: 2 years
Overall response rate (ORR)
time frame: 2 years

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

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

Additional Information

Official title Phase II Trial of Pemetrexed and Temozolomide in Treating Patients With Relapsed PCNSL
Description The best reported outcomes of PCNSL treatment are high-dose methotrexate-based chemotherapy combined with whole-brain radiation therapy (WBRT). Despite aggressive therapy, however, nearly 50% of patients will relapse within 24 months of diagnosis. Furthermore, the application of high-dose methotrexate-based regimen is complex, needing be hydrated, alkalified and detoxified, and treatment-related toxicity mortality is severe. In an attempt to improve upon these poor results and reduce treatment-related side effects, we will treat about 15-20 relapsed PCNSL patients who was fail in high-dose methotrexate-based chemotherapy. Our objective is to assess our treatment strategies' availability based on response rates, progression-free survival (PFS), median PFS, and toxicity.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Shandong Cancer Hospital and Institute.