A Phase II Study of Methotrexate and Thiotepa Chemotherapy for Patients With Newly Diagnosed Primary CNS Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
A Phase II Study of Methotrexate and Thiotepa Chemotherapy for Patients With Newly Diagnosed Primary CNS Lymphoma
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary CNS lymphoma
- Confirmed by 1 of the following:
- Brain biopsy or resection
- CSF cytology
- Positive cytology or immunohistochemical diagnosis of monoclonality
and measurable intracranial tumor
- Vitreal biopsy
- Measurable and contrast-enhancing disease on the postoperative, pretreatment MRI or
CT scan
- No radiographic evidence of ascites or pleural effusions
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 2.0 mg/dL
- SGOT no greater than 4 times upper limit of normal
Renal
- Creatinine no greater than 2 mg/dL
- Creatinine clearance at least 50 mL/min
Other
- Mini mental score of at least 15
- HIV negative
- Able to achieve hydration
- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ
- No allergy to methotrexate
- No serious infection
- No medical illness that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior immunotherapy or biologic therapy for this disease
Chemotherapy
- No prior chemotherapy for this disease
- No other concurrent chemotherapeutic agents
Endocrine therapy
- No prior hormonal therapy for this disease
- Prior glucocorticoid therapy allowed
Radiotherapy
- No prior radiotherapy for this disease
- No prior cranial irradiation
Surgery
- See Disease Characteristics
Other
- At least 1 week since prior salicylates, non-steroidal anti-inflammatory drugs,
probenecid, folic acid, or sulfonamide medications
- No other concurrent investigational agents
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete radiographic response
Safety Issue:
No
Principal Investigator
Tracy Batchelor, MD, MPH
Investigator Role:
Study Chair
Investigator Affiliation:
Massachusetts General Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000256605
NCT ID:
NCT00045539
Start Date:
October 2002
Completion Date:
January 2006
Related Keywords:
- Lymphoma
- primary central nervous system non-Hodgkin lymphoma
- Lymphoma
Name | Location |
|---|---|
| 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 |
