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Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00072449
Recruitment Status : Terminated (slow accrual and lack of resources and priority due to combining 2 consortia)
First Posted : November 6, 2003
Results First Posted : August 28, 2013
Last Update Posted : August 28, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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 study the effectiveness of rituximab in treating patients who have refractory or relapsed primary CNS lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Biological: rituximab Phase 2

Detailed Description:



  • Determine the radiographic response proportion in patients with refractory or recurrent primary CNS lymphoma treated with rituximab.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)
Study Start Date : May 2004
Actual Primary Completion Date : March 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: Rituximab monotherapy
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
Biological: rituximab

Primary Outcome Measures :
  1. Radiographic Response [ Time Frame: 1 month, 2 months and then q3months ]
    it at any time point patient progresses no more scans are required, patient is off study

Secondary Outcome Measures :
  1. Progression-free Survival [ Time Frame: pt had MRI q3months ]
    pt had MRI every 3 months

  2. Overall Survival [ Time Frame: 47 months ]
    survival was evaluated q 2months

  3. Toxicity [ Time Frame: 8 weeks - 2 cycles ]
    patients only received drug for 8 weeks

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.0 g/dL


  • Bilirubin less than 1.5 mg/dL
  • Transaminases less than 4 times upper limit of normal


  • Creatinine less than 1.5 mg/dL


  • 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


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])


  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • At least 3 months since prior radiotherapy


  • Not specified


  • Recovered from prior therapy
  • More than 90 days since prior investigational drugs
  • More than 90 days since prior use of a therapeutic device

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00072449

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United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
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Study Chair: Tracy Batchelor, MD, MPH Massachusetts General Hospital

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT00072449     History of Changes
Other Study ID Numbers: NABTT-2201 CDR0000339737
U01CA062475 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2003    Key Record Dates
Results First Posted: August 28, 2013
Last Update Posted: August 28, 2013
Last Verified: June 2013
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
primary central nervous system non-Hodgkin lymphoma
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents