A Phase II Study of Rituximab and Temozolomide in Recurrent Primary CNS Lymphoma
- Determine the response rate in patients with recurrent primary CNS non-Hodgkin's
lymphoma treated with rituximab, temozolomide, and methylprednisolone.
- Determine the overall and 6-month progression-free survival of patients treated with
OUTLINE: Induction therapy: Patients receive rituximab IV over 30-60 minutes on days 1, 8,
15, and 22 and oral temozolomide daily on days 1-7 and 15-21. After day 28, patients with
stable disease or better proceed to consolidation therapy.
Consolidation therapy: Patients receive oral temozolomide daily on days 1-5. Treatment
repeats every 28 days for up to 6 courses. Patients achieving a complete remission proceed
to maintenance therapy.
Maintenance therapy: Patients receive methylprednisolone IV over 2 hours on day 1. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within
approximately 13.3 months.
Masking: Open Label, Primary Purpose: Treatment
Response rate assessed by MRI every 2 months
Lauren E. Abrey, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|
|University of Wisconsin Paul P. Carbone Comprehensive Cancer Center||Madison, Wisconsin 53792-6164|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|UCSF Helen Diller Family Comprehensive Cancer Center||San Francisco, California 94115|
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|
|UPMC Cancer Centers||Pittsburgh, Pennsylvania 15232|