Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma

Lymphoma Clinical Trial

Official title: A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

• NCT number: NCT00072449
• Study type: Interventional
• Source: Sidney Kimmel Comprehensive Cancer Center
• Status: Terminated
• Phase: Phase 2
• Start date: May 2004
• Completion date: June 2010