A Phase II Study of Methotrexate and Thiotepa Chemotherapy for Patients With Newly Diagnosed Primary CNS Lymphoma
- Determine the complete radiographic response in patients with newly diagnosed primary
CNS lymphoma treated with methotrexate and thiotepa.
- Determine the duration of progression-free survival and overall survival of patients
treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine whether tumor expression of BCL-6 is associated with response to this
chemotherapy regimen and survival of these patients.
- Describe the relationship between initial response to steroids (if administered),
response to this chemotherapy regimen, and survival of these patients.
OUTLINE: This is a multicenter study.
Patients receive thiotepa IV over 15 minutes on day 1. Patients also receive methotrexate IV
over 4 hours on days 1 (8 hours after thiotepa) and 14. Beginning 24 hours after the start
of methotrexate infusion, patients receive leucovorin calcium IV or orally every 6 hours
until rescue is achieved. Treatment repeats every 28 days for up to 4 courses in the absence
of disease progression or unacceptable toxicity. Patients achieving disappearance of
enhancement of disease on MRI receive an additional 28-day course followed by maintenance
therapy comprising thiotepa and methotrexate once a month for 11 courses.
Patients undergo neuro-ophthalmologic exams annually for 2 years.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 23-39 patients will be accrued for this study within 8-20
Masking: Open Label, Primary Purpose: Treatment
Complete radiographic response
Tracy Batchelor, MD, MPH
Massachusetts General Hospital
United States: Federal Government
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Josephine Ford Cancer Center at Henry Ford Hospital||Detroit, Michigan 48202|
|Comprehensive Cancer Center at University of Alabama at Birmingham||Birmingham, Alabama 35294|
|Winship Cancer Institute of Emory University||Atlanta, Georgia 30322|
|H. Lee Moffitt Cancer Center and Research Institute at University of South Florida||Tampa, Florida 33612|