Phase I/II Trial of VELCADE Plus Zevalin in Patients With Relapsed or Refractory Follicular Lymphoma
Stopped early · Phase 1/Phase 2
Conditions studied: Lymphoma
In brief
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 the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving bortezomib together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells. This phase I/II trial is studying the side effects and best dose of bortezomib when given together with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they work in treating patients with relapsed or refractory follicular non-Hodgkin's lymphoma.
Key facts
- Study ID
- NCT00372905
- Run by
- Northwestern University
- People needed
- 18
- Starts
- 2007-07-24
- Expected to finish
- 2013-07-08
- Last updated by the study team
- 2019-09-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Emory University School of Medicine — Atlanta, Georgia, United States
- Northwestern University — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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