Phase II Pilot Study of Bortezomib (VELCADE®) and Gemcitabine for Patients With Relapsed or Refractory Hodgkin's Lymphoma
- Determine the overall response rate (partial and complete response) in patients with
relapsed or refractory Hodgkin's lymphoma treated with bortezomib and gemcitabine
- 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
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Primary Purpose: Treatment
Response rate after 2 courses of therapy
Jonathan W. Friedberg, MD
James P. Wilmot Cancer Center
United States: Federal Government
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|