Status:
TERMINATED
Phase I/II Trial of VELCADE Plus Zevalin in Patients With Relapsed or Refractory Follicular Lymphoma
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Robert H. Lurie Cancer Center
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block t...
Detailed Description
This is a phase I, dose-escalation study of bortezomib followed by a phase II study. Phase I: \- Induction therapy: Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15, and 22, rituxima...
Eligibility Criteria
Inclusion
- Histologically confirmed follicular lymphoma
- CD20+ at time of diagnosis or subsequently
- More than 4 weeks since prior rituximab
- More than 3 weeks since prior anticancer therapy (6 weeks for nitrosourea or mitomycin C)
- More than 4 weeks since prior major surgery
- More than 2 weeks since prior investigational drugs
Exclusion
- AIDS-related lymphoma
- History or evidence of CNS involvement
- Pregnant or nursing
- known HIV positivity
- serious medical or psychiatric illness that would preclude study participation
- myocardial infarction within the past 6 months
- congestive heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia or active conduction system abnormalities
- known hypersensitivity to rituximab, bortezomib, boron, or mannitol
- prior autologous or allogeneic stem cell transplantation
- prior radioimmunoconjugate therapy or prior exposure to murine antibodies
- prior external-beam irradiation to \> 25% of active bone marrow
Key Trial Info
Start Date :
July 24 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00372905
Start Date
July 24 2007
End Date
July 8 2013
Last Update
September 4 2019
Active Locations (2)
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1
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
2
Northwestern University
Chicago, Illinois, United States, 60611