Status:
TERMINATED
Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
OBJECTIVES: Primary * Determine the radiographic response proportion in patients with refractory or recurrent primary CNS lymphoma treated with rituximab. Secondary * Determine the progression-fre...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00072449
Start Date
May 1 2004
End Date
June 1 2010
Last Update
August 28 2013
Active Locations (9)
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1
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
2
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
3
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
4
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410