A Pilot Study of Combined Immunochemotherapy Followed by Reduced Dose RT for Patients With Newly Diagnosed PCNSL
- Determine the efficacy of induction immunochemotherapy comprising rituximab,
methotrexate, procarbazine, and vincristine followed by reduced-dose radiotherapy and
consolidation cytarabine in patients with newly diagnosed primary central nervous
- Determine the 2-year and overall disease-free survival of patients treated with this
- Determine the progression-free and overall survival of patients treated with this
- Determine the acute treatment-related toxicity and safety of this regimen in these
- Determine the initial response rate of patients treated with immunochemotherapy.
- Determine the relapse rate after complete response in patients treated with this
- Determine the neuro-cognitive outcome in patients treated with this regimen.
OUTLINE: This is a multicenter, pilot study.
- Induction immunochemotherapy: Patients receive rituximab IV over 5 hours on day 1 and
methotrexate IV over 2 hours and vincristine IV over several minutes on day 2. Patients
also receive oral procarbazine on days 2-8 during courses 1, 3, and 5. Treatment
repeats every 2 weeks for 5 courses in the absence of disease progression or
unacceptable toxicity. Patients with a partial response after 5 courses may receive an
additional 2 courses.
- Radiotherapy: Beginning 3-5 weeks after completion of induction immunochemotherapy,
patients undergo radiotherapy daily 5 days a week for 3-6 weeks.
- Consolidation chemotherapy: Patients receive cytarabine IV over 3 hours on days 1 and
2. Treatment repeats every 28 days for a total of 2 courses.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 3 years.
Primary Purpose: Treatment
Treatment related toxicity assessed by NCI CTC
Lauren E. Abrey, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Hillman Cancer Center at University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15236|
|Vermont Cancer Center at University of Vermont||Burlington, Vermont 05405-0075|
|University of Virginia Cancer Center||Charlottesville, Virginia 22908|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Kentuckiana Cancer Institute, PLLC||Louisville, Kentucky 40202|