Bortezomib, Doxorubicin Hydrochloride Liposome, and Rituximab in Treating Patients With Diffuse Large B-Cell Lymphoma That Has Relapsed or Not Responded to Treatment
Part of paid clinical trials in Buffalo, New York.
- Sponsor
- Roswell Park Cancer Institute
- Study ID
- NCT00851552
- Phase
- PHASE2
- Status
- Terminated
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- rituximab — BIOLOGICALGiven IV
- bortezomib — DRUGGiven IV
- pegylated liposomal doxorubicin hydrochloride — DRUGGiven IV
- gene expression analysis — GENETICCorrelative Study
- polymerase chain reaction — GENETICCorrelative Study
- polymorphism analysis — GENETICCorrelative Study
- proteomic profiling — GENETICCorrelative Study
- flow cytometry — OTHERCorrelative Study
- laboratory biomarker analysis — OTHERCorrelative Study
Study Details
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer cell 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 cell-killing substances to them. Giving bortezomib together with doxorubicin hydrochloride liposome and rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with doxorubicin hydrochloride liposome and rituximab works in treating patients with diffuse large B-Cell lymphoma that has relapsed or not responded to treatment.
Key Dates
- Start date
- Jan 31, 2009
- Status verified
- Jun 2014
- Primary completion
- Sep 30, 2011
- Completion
- Sep 30, 2011
Study Design
- Enrollment
- 9 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Primary Outcome Measure
Antitumor Efficacy in Terms of Overall, Complete, and Partial Response Rates and Time to Progression at Weeks 9 and 21 [ Time Frame: at weeks 9 and 21 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | - |
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