Zevalin and Velcade in Relapsed/Refractory Mantle Cell Lymphoma
| Status: | Recruiting |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | February 2012 |
| End Date: | March 2020 |
| Contact: | Anne Beaven, MD |
| Email: | Anne.Beaven@duke.edu |
| Phone: | 919-684-8964 |
A Phase II Study Evaluating Combined Zevalin(Ibritumomab Tiuxetan)and Velcade(Bortezomib)in Relapsed/Refractory Mantle Cell Lymphoma
The purpose of this study is to evaluate the effects (good and bad) of the combination of
ibritumomab tiuxetan (Zevalin) and bortezomib (Velcade) in patients with relapsed/refractory
mantle cell lymphoma.
Zevalin is a monoclonal antibody that is combined with a radioactive substance and given
with another monoclonal antibody called rituximab (Rituxan). It works by attaching to
cancer cells and releasing radiation to damage those cells. both Zevalin and Rituxan are
given in this study, along with Velcade.
ibritumomab tiuxetan (Zevalin) and bortezomib (Velcade) in patients with relapsed/refractory
mantle cell lymphoma.
Zevalin is a monoclonal antibody that is combined with a radioactive substance and given
with another monoclonal antibody called rituximab (Rituxan). It works by attaching to
cancer cells and releasing radiation to damage those cells. both Zevalin and Rituxan are
given in this study, along with Velcade.
Inclusion Criteria:
- Patients with relapsed or refractory Mantle Cell lymphoma with measurable disease.
- Age > 18 years old
- Expected survival >/= 3 months
- ECOG performance status of 0, 1 or 2 at initiation of study (Appendix I).
- Laboratory tests meet the levels specified in the protocol
Exclusion Criteria:
- Patients must not have received chemotherapy, radiation or surgical resection of
malignancy within 3 weeks of study initiation. However, if they have received
nitrosurea or mitomycin C then they should not be enrolled in the study until 6 weeks
after therapy was last received.
- No limitations to number of prior therapies
- No prior radioimmunotherapy (RIT)
- Prior bortezomib is allowed
- Patient must be fully recovered from all toxicities associated with prior surgery,
radiation treatment, chemotherapy or immunotherapy.
- No active, serious infection or medical or psychiatric illness likely to interfere
with participation in this clinic trial
- No known HIV infection
- No active CNS involvement
- Bone Marrow Involvement >/= 25% within 30 days of initiation of study treatment
- Pregnant or breast feeding
- No patients who have received G-CSF or GM-CSF within the 14 days prior to initiating
protocol
- No patient who has had major surgery within the four weeks prior to initiating
protocol therapy
- No patients with pleural effusion or significant ascites
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