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Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma

This study has been terminated.
(slow accrual and lack of resources and priority due to combining 2 consortia)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00072449
First received: November 4, 2003
Last updated: June 14, 2013
Last verified: June 2013

November 4, 2003
June 14, 2013
May 2004
March 2009   (final data collection date for primary outcome measure)
Radiographic Response [ Time Frame: 1 month, 2 months and then q3months ] [ Designated as safety issue: No ]
it at any time point patient progresses no more scans are required, patient is off study
Not Provided
Complete list of historical versions of study NCT00072449 on ClinicalTrials.gov Archive Site
  • Progression-free Survival [ Time Frame: pt had MRI q3months ] [ Designated as safety issue: No ]
    pt had MRI every 3 months
  • Overall Survival [ Time Frame: 47 months ] [ Designated as safety issue: No ]
    survival was evaluated q 2months
  • Toxicity [ Time Frame: 8 weeks - 2 cycles ] [ Designated as safety issue: Yes ]
    patients only received drug for 8 weeks
Not Provided
Not Provided
Not Provided
 
Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma
A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)

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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
Biological: rituximab
Experimental: Rituximab monotherapy
Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
Intervention: Biological: rituximab
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
June 2010
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00072449
NABTT-2201 CDR0000339737, U01CA062475, NABTT-2201
Not Provided
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Tracy Batchelor, MD, MPH Massachusetts General Hospital
Sidney Kimmel Comprehensive Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP