A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)
rituximab
Hemic and Lymphatic Diseases+5
+ Immune System Diseases
+ Immunoproliferative Disorders
Treatment Study
Summary
Study start date: May 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, United StatesOpen Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham in Google MapsH. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, United StatesWinship Cancer Institute of Emory University
Atlanta, United StatesSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, United States