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Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma Clinical research trials and Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma. Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma clinical trial. Subjects frequently get the best healthcare possible for their Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma  Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma
Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma
For Condition: primary central nervous system lymphoma
Status: Not yet recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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 relapsedprimary CNS lymphoma.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TracyBatchelor, Study Chair, Massachusetts General Hospital
Additional Information:
Study ID Numbers: CDR0000339737; NABTT-2201
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072449
Other Primary Central Nervous System Lymphoma Studies:
1. Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma
2. Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
3. Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
4. Antineoplaston Therapy in Treating Patients With Primary Central Nervous System Lymphoma
5. Methotrexate, Cyclophosphamide, and Etoposide Phosphate Given With Osmotic Blood-Brain Barrier Disruption Plus Dexamethasone and Cytarabine in Treating Patients With Primary CNS Lymphoma
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Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma
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