Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
|ClinicalTrials.gov Identifier: NCT00045539|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
RATIONALE: Drugs used in chemotherapy, such as methotrexate and thiotepa, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining methotrexate with thiotepa in treating patients who have newly-diagnosed primary CNS lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: leucovorin calcium Drug: methotrexate Drug: thiotepa||Phase 2|
- 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 months.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Methotrexate and Thiotepa Chemotherapy for Patients With Newly Diagnosed Primary CNS Lymphoma|
|Study Start Date :||October 2002|
|Actual Study Completion Date :||January 2006|
- Complete radiographic response
- Duration of progression-free survival and overall survival
- Association of tumor BCL-6 expression with response
- Relationship among initial response to steroids, response to chemotherapy, and survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00045539
|United States, Alabama|
|Comprehensive Cancer Center at University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294-3410|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute at University of South Florida|
|Tampa, Florida, United States, 33612-9497|
|United States, Georgia|
|Winship Cancer Institute of Emory University|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|Josephine Ford Cancer Center at Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, North Carolina|
|Comprehensive Cancer Center at Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157-1096|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Study Chair:||Tracy Batchelor, MD, MPH||Massachusetts General Hospital|