Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Temporarily closed 18 and over NCI NABTT-2201 NCT00072449

Objectives

Primary

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

Secondary

1. Determine the progression-free and overall survival of patients treated with this drug.
2. Determine the toxicity profile of this drug in these patients.

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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

A total of 15-25 patients will be accrued for this study within 5-9 months.

Outcomes

Radiographic response

Progression-free survival
Overall survival
Toxicity

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.

Trial Contact Information

Trial Lead Organizations

New Approaches to Brain Tumor Therapy

Tracy Batchelor, MD, MPH, Protocol chair		Ph: 617-643-1938; 877-726-5130

Registry Information
Official Title		A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)
Trial Start Date		2004-05-06
Trial Completion Date		2005-09-18 (estimated)
Registered in ClinicalTrials.gov		NCT00072449
Date Submitted to PDQ		2003-10-01
Information Last Verified		2007-11-04
NCI Grant/Contract Number		CA062475

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