Bortezomib and Gemcitabine Hydrochloride in Treating 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Pilot Study of Bortezomib (VELCADE®) and Gemcitabine for Patients With Relapsed or Refractory Hodgkin's Lymphoma|
- Response rate after 2 courses of therapy [ Time Frame: 21 Days/course for up to 6 courses ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: 21 Days/course for up to 6 courses ] [ Designated as safety issue: No ]
|Study Start Date:||April 2005|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
|Experimental: Bortezomib, Gemcitabine Hdrochloride||Drug: bortezomib Drug: gemcitabine hydrochloride|
- Determine the overall response rate (partial and complete response) in patients with relapsed or refractory Hodgkin's lymphoma treated with bortezomib and gemcitabine hydrochloride.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262860
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|James P. Wilmot Cancer Center at University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Jonathan W. Friedberg, MD||James P. Wilmot Cancer Center|