a Phase II Study in Primary Central Nervous System Lymphoma
Status:
Unknown status
Trial end date:
2011-11-01
Target enrollment:
Participant gender:
Summary
In this study we will test the hypothesis that concurrent chemoradiation (CCRT) with
temozolomide after induction chemotherapy by conventional high-dose methotrexate (HD-MTX)
plus dexamethasone may be an effective and well tolerated treatment for immunocompetent
patients with PCSNL. Corticosteroid can effectively reduce brain edema and corticosteroid
alone has resulted in complete or partial remission in about 40% patients with PCNSL. To
enhance local disease control, CCRT with temozolomide will be used in the study. Temozolomide
is a well-tolerated oral alkylating agent that is able to permeate the BBB. Concurrent
temozolomide with WBRT has shown superior effect to WBRT alone for the treatment of
metastatic brain tumors and glioblastoma multiforme. In addition, temozolomide has
single-agent activity for PCNSL (21% CR in relapsed or refractory PCNSL in a phase II trial).
This is an open-label, non-randomized, multi-center phase II study. The primary end point of
is the complete response rate. This study is a two-stage design for testing non-inferiority
of the proposed treatment as compared to the approximately 80% response rate reported for
conventional treatment. Assuming a non-inferiority margin of 20%, a sample size of 25
subjects, which provides an 80% power for establishment of non-inferiority. At the first
stage, 15 subjects are to be enrolled. If equal to or more than 6 patients achieve complete
response, the study would accrue additional 10 subjects. The treatment regimen is as follows.
Induction chemotherapy: MS regimen (repeated every 14 days, total 4 cycles)
- Methotrexate 3.5 g/m2 i.v. infusion 4 hours on day1
- Methylprednisolone 200 mg/m2/day i.v. infusion 30 minutes, on day1-4 Concurrent
chemoradiotherapy (CCRT)
- Whole brain radiation therapy (WBRT) 2 Gy per fraction daily, 5 days per week
Temozolomide 75 mg/m2/day orally daily, only on the days of WBRT
Phase:
Phase 2
Details
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborators:
Chi Mei Medical Hospital China Medical University Hospital Mackay Memorial Hospital National Cheng-Kung University Hospital National Taiwan University Hospital Taichung Veterans General Hospital