NCT01735747

Temozolomide, Nedaplatin, Vincristine, and Radiotherapy as First-line Treatment in Newly Diagnosed Primary CNS Lymphoma

Phase Ⅱ Trial of Temozolomide Plus Concurrent Whole-Brain Radiation Followed by TNV Regimen as Adjuvant Therapy for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma (PCNSL)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Rongjie Tao · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In this trial, we will treat newly diagnosed PCNSL with temozolomide, nedaplatin, vincristine (TNV) as the replacement of high-dose methotrexate to combine with concurrent chemoradiotherapy. 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\[3,4\]. In an attempt to improve upon these poor results and reduce treatment-related side effects, we will treat about 15-20 PCNSL patients with temozolomide concurrent chemoradiotherapy at the outset and then adjuvant chemotherapy for 6 cycles with temozolomide, nedaplatin, vincristine, as part of front-line therapy. 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
RADIATION	Radiotherapy	WBRT was given five times a week at 2 gray (Gy)/d until the whole brain radiotherapy dose reached 40 gray. The patients were given concurrent temozolomide (75mg/m2, orally) daily during radiotherapy until the end of radiotherapy.
DRUG	nedaplatin	nedaplatin (80mg/m2 i.v., day 1), 28 day schedule, performed four weeks after radiotherapy.A maximum of six cycles were applied.
DRUG	vincristine	vincristine (1.4mg/m2 i.v., day 1)28 day schedule,performed four weeks after radiotherapy.A maximum of six cycles were applied.
DRUG	Temozolomide	Temozolomide (200mg/m2 orally, days 1-5, Each cycle was 4 weeks ), performed four weeks after radiotherapy. A maximum of six cycles were applied.

Timeline

• Start date: 2008-06-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-11-28
• Last updated: 2013-03-12

Locations

1 site across 1 country: China