Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma - Article
Clinical Trial: Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
This study is currently recruiting patients.
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.
|Condition||Treatment or Intervention||Phase|
|primary central nervous system lymphoma || Drug: leucovorin calcium |
|Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Lymphoma; Neurologic Diseases
Study Type: Interventional
Study Design: Treatment
- 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.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
- 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
- Karnofsky 60-100%
- Not specified
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 2.0 mg/dL
- SGOT no greater than 4 times upper limit of normal
- Creatinine no greater than 2 mg/dL
- Creatinine clearance at least 50 mL/min
- 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 chemotherapy for this disease
- No other concurrent chemotherapeutic agents
- No prior radiotherapy for this disease
- No prior cranial irradiation
- See Disease Characteristics
- At least 1 week since prior salicylates, non-steroidal anti-inflammatory drugs, probenecid, folic acid, or sulfonamide medications
- No other concurrent investigational agents
Location and Contact Information
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, 35294-3410, United States; Recruiting
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida, 33612-9497, United States; Recruiting
Winship Cancer Institute of Emory University, Atlanta, Georgia, 30322, United States; Recruiting
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, 21231-2410, United States; Recruiting
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, 02114, United States; Recruiting
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, 48202, United States; Recruiting
Comprehensive Cancer Center at Wake Forest University, Winston Salem, North Carolina, 27157-1082, United States; Recruiting
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195, United States; Recruiting
Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania, 19104-4283, United States; Recruiting
Tracy Batchelor, MD, Study Chair, Massachusetts General Hospital
Record last reviewed: November 2004
Last Updated: March 28, 2005
Record first received: September 6, 2002
ClinicalTrials.gov Identifier: NCT00045539
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005
- Central Nervous System Lymphoma, Primary (National Cancer Institute)