Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: rituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab monotherapy<br>Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks | Biological: rituximab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Response | it at any time point patient progresses no more scans are required, patient is off study | 1 month, 2 months and then q3months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | pt had MRI every 3 months | pt had MRI q3months | 
| Overall Survival | survival was evaluated q 2months | 47 months | 
| Toxicity | patients only received drug for 8 weeks | 8 weeks - 2 cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary central nervous system non-Hodgkin lymphoma