NCT01985451

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Rongjie Tao · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	Pemetrexe	Patients with relapsed PCNSL patients were treated with high-dose pemetrexed (900mg/m²).
DRUG	Temozolomide	Patients with relapsed PCNSL patients were treated with temozolomide (200mg/m² day 1-5,28).

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-11-15
• Last updated: 2013-11-15