Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma
NCT ID: NCT00072449
Last Updated: 2013-08-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
12 participants
INTERVENTIONAL
2004-05-31
2010-06-30
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rituximab monotherapy
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
rituximab
Interventions
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rituximab
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Tracy Batchelor, MD, MPH
Role: STUDY_CHAIR
Massachusetts General Hospital
Locations
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Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Batchelor TT, Grossman SA, Mikkelsen T, Ye X, Desideri S, Lesser GJ. Rituximab monotherapy for patients with recurrent primary CNS lymphoma. Neurology. 2011 Mar 8;76(10):929-30. doi: 10.1212/WNL.0b013e31820f2d94. No abstract available.
Other Identifiers
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NABTT-2201
Identifier Type: -
Identifier Source: secondary_id
NABTT-2201 CDR0000339737
Identifier Type: -
Identifier Source: org_study_id