Non Hodgkin Lymphoma Clinical Trial
Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma
Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have refractory or relapsed primary CNS lymphoma.
Full Description
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.
Eligibility 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
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There are 9 Locations for this study
Birmingham Alabama, 35294, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Baltimore Maryland, 21231, United States
Boston Massachusetts, 02114, United States
Detroit Michigan, 48202, United States
Winston-Salem North Carolina, 27157, United States
Cleveland Ohio, 44195, United States
Philadelphia Pennsylvania, 19104, United States
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