A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)
18 Years
N/A
Both
Lymphoma
Trial Information
A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)
OBJECTIVES:
Primary
- Determine the radiographic response proportion in patients with refractory or recurrent
primary CNS lymphoma treated with rituximab.
Secondary
- Determine the progression-free and overall survival of patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 28 days for
2 courses in the absence of disease progression or unacceptable toxicity. Patients may
receive additional courses of rituximab off study at the discretion of the treating
physician.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 5-9
months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed primary CNS lymphoma based on 1 of the following:
- Histologically confirmed non-Hodgkin's B-cell lymphoma by brain biopsy or
resection
- Positive cerebrospinal fluid (CSF) cytology or immunohistochemical diagnosis of
CSF monoclonality with or without measurable intracranial disease
- Histologically confirmed vitreal lymphoma with measurable intracranial tumor
- CD20 positive by brain biopsy
- Measurable (greater than 1 cm in diameter) tumor by CT scan or MRI
- Progressed during first-line chemotherapy and/or radiotherapy OR relapsed after
initial successful treatment
- No systemic lymphoma by CT scan of the chest, abdomen, and pelvis with contrast
- No leptomeningeal lymphoma by lumbar puncture for CNS cytology/flow cytometry
- No ocular lymphoma by slit lamp examination
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
- Hemoglobin at least 9.0 g/dL
Hepatic
- Bilirubin less than 1.5 mg/dL
- Transaminases less than 4 times upper limit of normal
Renal
- Creatinine less than 1.5 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 1 year after study
participation
- HIV negative
- Mini mental status examination score at least 15
- No concurrent serious infection
- No other medical illness that would preclude study treatment
- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 90 days since prior biologic therapy
- No prior rituximab
- No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF] or sargramostim
[GM-CSF])
Chemotherapy
- See Disease Characteristics
- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 3 months since prior radiotherapy
Surgery
- Not specified
Other
- Recovered from prior therapy
- More than 90 days since prior investigational drugs
- More than 90 days since prior use of a therapeutic device
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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:
NABTT-2201 CDR0000339737
NCT ID:
NCT00072449
Start Date:
May 2004
Completion Date:
June 2010
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 |
| 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 |
| Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Tampa, Florida 33612 |
| Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham, Alabama 35294 |
