Clinical Trial: Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma

This study is currently recruiting patients.

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)


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 Treatment or Intervention Phase
primary central nervous system lymphoma
 Drug: leucovorin calcium
 Drug: methotrexate
 Drug: thiotepa
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lymphoma;   Neurologic Diseases

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Methotrexate and Thiotepa in Patients With Newly Diagnosed Primary CNS Lymphoma

Further Study Details: 


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


  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • 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



  • No prior chemotherapy for this disease
  • No other concurrent chemotherapeutic agents

Endocrine therapy


  • No prior radiotherapy for this disease
  • No prior cranial irradiation


  • See Disease Characteristics


Location and Contact Information

      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3410,  United States; Recruiting
James M. Markert, MD  205-975-6985 

      H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa,  Florida,  33612-9497,  United States; Recruiting
Steven Brem, MD  813-979-3063 

      Winship Cancer Institute of Emory University, Atlanta,  Georgia,  30322,  United States; Recruiting
David H. Lawson, MD  404-778-4189 

      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States; Recruiting
John J. Laterra, MD, PhD  410-955-8964 

      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States; Recruiting
Fred H. Hochberg, MD  617-726-8657 

      Josephine Ford Cancer Center at Henry Ford Health System, Detroit,  Michigan,  48202,  United States; Recruiting
Mark L. Rosenblum, MD  313-916-1340 

North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States; Recruiting
Glenn J. Lesser, MD  336-716-9527 

      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States; Recruiting
David M. Peereboom, MD  216-445-6068 

      Abramson Cancer Center at the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104-4283,  United States; Recruiting
Kevin Judy, MD  215-662-7854 

Study chairs or principal investigators

Tracy Batchelor, MD,  Study Chair,  Massachusetts General Hospital   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000256605; NABTT-2109; JHOC-NABTT-2109; NCT00045539
Record last reviewed:  November 2004
Last Updated:  March 28, 2005
Record first received:  September 6, 2002 Identifier:  NCT00045539
Health Authority: United States: Federal Government processed this record on 2005-04-08

Cache Date: April 9, 2005