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Rituximab, Temozolomide, and Methylprednisolone in Treating Patients With Recurrent Primary CNS Non-Hodgkin's 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: NCT00248534
Recruitment Status : Terminated (slow accrual/lack of resources/low priority due to combining 2 consortia)
First Posted : November 4, 2005
Results First Posted : September 4, 2018
Last Update Posted : September 4, 2018
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 block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as temozolomide and methylprednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Rituximab may help chemotherapy kill more cancer cells by making cancer cells more sensitive to the drugs. Giving rituximab together with temozolomide and methylprednisolone may be an effective treatment for primary CNS non-Hodgkin's lymphoma.

PURPOSE: This phase II trial is studying how well giving rituximab together with temozolomide and methylprednisolone works in treating patients with recurrent primary CNS non-Hodgkin's lymphoma.

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

Detailed Description:



  • Determine the response rate in patients with recurrent primary CNS non-Hodgkin's lymphoma treated with rituximab, temozolomide, and methylprednisolone.


  • Determine the overall and 6-month progression-free survival of patients treated with this regimen.

OUTLINE: Induction therapy: Patients receive rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 and oral temozolomide daily on days 1-7 and 15-21. After day 28, patients with stable disease or better proceed to consolidation therapy.

Consolidation therapy: Patients receive oral temozolomide daily on days 1-5. Treatment repeats every 28 days for up to 6 courses. Patients achieving a complete remission proceed to maintenance therapy.

Maintenance therapy: Patients receive methylprednisolone IV over 2 hours on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within approximately 13.3 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Rituximab and Temozolomide in Recurrent Primary CNS Lymphoma
Study Start Date : September 2005
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Experimental: IV Rituximab

IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks.

Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide [TMZ] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression

Biological: rituximab
given IV days 1,8, 15 and 22

Drug: methylprednisolone
2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)

Drug: temozolomide
Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles
Other Name: TMZ

Primary Outcome Measures :
  1. Percentage of Participants With Objective Response [ Time Frame: 2 months ]
    Objective response rate of the combination of Rituximab and TMZ

Secondary Outcome Measures :
  1. Number of Participants Alive at 3 Years [ Time Frame: 3 years ]
    The intent was to measure Median Overall Survival at 3 years, however only one participant was analyzable at this time point. Therefore, the number of participants who survived is reported instead.

  2. 1 Year Overall Survival Rate [ Time Frame: 1 year ]
  3. 6-month Progression-free Survival [ Time Frame: 6 months ]

    Scan at 6 months

    Complete response: Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable or improving neurological exam minimum of 4 wks

    Partial response: Greater than or equal 50% reduction in tumor size on MRI, on sable or decreasing glucocorticoids with stable or improving neurological exam for a minimum of 4 wks.

    Progressive disease: Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.

    Stable disease: Clinical status and MRI does not qualify for complete response, partial response or progression

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 to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed primary CNS non-Hodgkin's lymphoma by brain biopsy, positive cerebrospinal fluid cytology, or vitrectomy

    • Recurrent disease
  • Measurable disease, define as bi-dimensionally measurable lesions with clearly defined margins by brain MRI or CT scan

    • Radiographical evidence of tumor progression by MRI or CT scan
    • Steroid therapy must be stable for 5 days prior to scan



  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • More than 8 weeks


  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL (transfusion allowed)


  • SGOT < 2 times upper limit of normal (ULN)
  • Bilirubin < 2 times ULN
  • No active or latent hepatitis B infection


  • Creatinine < 1.5 mg/dL OR
  • Creatinine clearance ≥ 60 mL/min


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No uncontrolled significant medical illness that would preclude study treatment
  • No active infection
  • No active HIV infection
  • No concurrent disease that would dangerously alter drug metabolism or obscure toxicity


Biologic therapy

  • At least 7 days since prior interferon or thalidomide
  • No concurrent prophylactic filgrastim (G-CSF)
  • No concurrent immunotherapy


  • No prior temozolomide
  • At least 14 days since prior methotrexate
  • At least 21 days since prior procarbazine
  • At least 42 days since prior nitrosoureas
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • At least 7 days since prior tamoxifen
  • No concurrent hormonal therapy


  • No concurrent radiotherapy


  • Not specified


  • Recovered from all prior therapy
  • At least 28 days since prior investigational agents
  • At least 28 days since other prior cytotoxic therapy
  • At least 7 days since other prior non-cytotoxic agents (e.g., tretinoin) (radiosenitizers allowed)
  • No other concurrent investigational drugs

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): NCT00248534

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United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-6220
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
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Study Chair: Lauren E. Abrey, MD Memorial Sloan Kettering Cancer Center
Publications of Results:
Nayak L, Abrey LE, Drappatz J, et al.: Multicenter phase II trial of temozolomide (TMZ) and rituximab (RIT) for recurrent primary CNS lymphoma (PCNSL): North American Brain Tumor Consortium (NABTC) study 05-01. [Abstract] J Clin Oncol 29 (Suppl 15): A-2039, 2011.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT00248534    
Other Study ID Numbers: NABTC05-01
CDR0000445289 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2012-02673 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
U01CA062399 ( U.S. NIH Grant/Contract )
First Posted: November 4, 2005    Key Record Dates
Results First Posted: September 4, 2018
Last Update Posted: September 4, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents