Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma

Phase 2

Terminated

• Conditions: Lymphoma
• Interventions: Biological: rituximab

• Registration Number: NCT00072449
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2003-11-04
• Study First Submitted QC: 2003-11-05
• Study First Posted: 2003-11-06
• Study Start: 2004-05
• Primary Completion: 2009-03
• Study Completion: 2010-06
• Status Verified: 2013-06
• Results First Submitted: 2013-06-14
• Results First Submitted QC: 2013-06-14
• Last Update Submitted: 2013-06-14
• Results First Posted: 2013-08-28
• Last Update Posted: 2013-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab monotherapy	rituximab	Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks

Primary Outcome Measures

Name	Time	Method
Radiographic Response	1 month, 2 months and then q3months	it at any time point patient progresses no more scans are required, patient is off study

Secondary Outcome Measures

Name	Time	Method
Toxicity	8 weeks - 2 cycles	patients only received drug for 8 weeks
Progression-free Survival	pt had MRI q3months	pt had MRI every 3 months
Overall Survival	47 months	survival was evaluated q 2months

Trial Locations

Locations (9)

Winship Cancer Institute of Emory University; 🇺🇸 Atlanta, Georgia, United States

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Cleveland Clinic Taussig Cancer Center; 🇺🇸 Cleveland, Ohio, United States

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham; 🇺🇸 Birmingham, Alabama, United States

Josephine Ford Cancer Center at Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida; 🇺🇸 Tampa, Florida, United States

Wake Forest University Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States