Lymphoma Clinical Trial
Official title:
Phase II Pilot Study of Bortezomib (VELCADE®) and Gemcitabine for Patients With Relapsed or Refractory Hodgkin's Lymphoma
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work
in different ways to stop the growth of cancer cells, either by killing the cells or by
stopping them from dividing. Giving bortezomib together with gemcitabine hydrochloride may
kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with
gemcitabine hydrochloride works in treating patients with relapsed or refractory Hodgkin's
lymphoma.
OBJECTIVES:
Primary
- Determine the overall response rate (partial and complete response) in patients with
relapsed or refractory Hodgkin's lymphoma treated with bortezomib and gemcitabine
hydrochloride.
Secondary
- Determine the safety and toxic effects of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
- Correlate NF-kB inhibition and proteasome activity with response in patients treated
with this regimen.
OUTLINE: This is a multicenter, pilot study.
Patients receive bortezomib IV on days 1, 4, 8, and 11 and gemcitabine hydrochloride IV over
30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 2 years and then
annually thereafter.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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