NCT00072449TerminatedPhase 2
A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins18 sites in 1 country12 target enrollmentStarted: May 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Enrollment
- 12
- Locations
- 18
- Primary Endpoint
- Radiographic Response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Radiographic Response
Time Frame: 1 month, 2 months and then q3months
it at any time point patient progresses no more scans are required, patient is off study
Secondary Outcomes
- Progression-free Survival(pt had MRI q3months)
- Overall Survival(47 months)
- Toxicity(8 weeks - 2 cycles)
Investigators
Study Sites (18)
Loading locations...
Similar Trials
Withdrawn
Phase 2
Rituximab Plus Cyclophosphamide in Treating Patients With Indolent Stage III or Stage IV Non-Hodgkin's LymphomaLymphomaNCT00003605Hoag Memorial Hospital Presbyterian
Withdrawn
Phase 2
Rituximab and Dexamethasone in Treating Patients With Recurrent or Refractory Indolent Non-Hodgkin's LymphomaLymphomaNCT00003663Hoag Memorial Hospital Presbyterian
Completed
Phase 2
Vaccine Therapy and Sargramostim After Rituximab in Treating Patients With Refractory or Progressive Non-Hodgkin's LymphomaLymphomaNCT00071955Genitope Corporation
Unknown
Phase 2
Combination Chemotherapy Plus Rituximab in Treating Patients With Intermediate-Grade or High-Grade Non-Hodgkin's LymphomaLymphomaNCT00005959Amgen
Completed
Phase 2
Rituximab and Cladribine in Treating Patients With Newly Diagnosed Non-Hodgkin's LymphomaLymphomaNCT00053027Alliance for Clinical Trials in Oncology30