Zevalin and Velcade in Relapsed/Refractory Mantle Cell Lymphoma

• Status: Terminated
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborator: Spectrum Pharmaceuticals, Inc
• Treatments: Antibodies, Monoclonal; Bortezomib; Rituximab

Criteria

Inclusion Criteria:

• Patients with relapsed or refractory Mantle Cell lymphoma with measurable disease.

• Age > 18 years old

• Expected survival >/= 3 months

• Eastern Cooperative Oncology Group (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 central nervous system (CNS) involvement

• Bone Marrow Involvement >/= 25% within 30 days of initiation of study treatment

• Pregnant or breast feeding

• No patients who have received Granulocyte colony-stimulating factor (G-CSF) or Granulocyte macrophage colony-stimulating factor (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