Non Hodgkin Lymphoma Clinical Trial

Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma

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.

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Full Description

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

12

Study ID:

NCT00072449

Recruitment Status:

Terminated

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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There are 9 Locations for this study

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Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham Alabama, 35294, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa Florida, 33612, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit Michigan, 48202, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

12

Study ID:

NCT00072449

Recruitment Status:

Terminated

Sponsor:


Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

How clear is this clinincal trial information?

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