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A Phase II Study of Methotrexate and Thiotepa Chemotherapy for Patients With Newly Diagnosed Primary CNS Lymphoma

Phase 2
18 Years
Not Enrolling

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Trial Information

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

Inclusion Criteria


- 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


Biologic therapy

- No prior immunotherapy or biologic therapy for this disease


- No prior chemotherapy for this disease

- No other concurrent chemotherapeutic agents

Endocrine therapy

- No prior hormonal therapy for this disease

- Prior glucocorticoid therapy allowed


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete radiographic response

Safety Issue:


Principal Investigator

Tracy Batchelor, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital


United States: Federal Government

Study ID:




Start Date:

October 2002

Completion Date:

January 2006

Related Keywords:

  • Lymphoma
  • primary central nervous system non-Hodgkin lymphoma
  • Lymphoma



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