A Phase II Study of Rituximab and Temozolomide in Recurrent Primary CNS Lymphoma
OBJECTIVES:
Primary
- Determine the response rate in patients with recurrent primary CNS non-Hodgkin's
lymphoma treated with rituximab, temozolomide, and methylprednisolone.
Secondary
- Determine the overall and 6-month progression-free survival of patients treated with
this regimen.
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Response rate assessed by MRI every 2 months
No
Lauren E. Abrey, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000445289
NCT00248534
September 2005
Name | Location |
---|---|
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 |