Phase II Study of CHOP/Rituxan Plus VELCADE in Mediastinal Large B-cell Lymphoma
- This is a single arm phase 2 study of CHOP/Rituxan plus VELCADE followed by involved
field radiotherapy designed to evaluate the complete response to chemotherapy as
determined by PET scan following six cycles of therapy. One cycle equals 21 days.
- For each cycle, on Day 1, the patient will receive VELCADE intravenously, followed by
rituxan, and then followed by CHOP chemotherapy. Before receiving these drugs, the
patient will be given standard medications (Tylenol, Benadryl) to help minimize side
effects. They will also continue to take prednisone by mouth on days 2, 3, 4, and 5.
On Day 4, the patient will receive another dose of VELCADE.
- Before the beginning of every cycle of study treatment, the following will be
performed: Medical history; physical examination; and routine blood tests. After the
3rd and 6th cycle of study treatment, the patient will have tests to monitor the status
of their disease. These include PET scan, CT scans, and standard blood tests.
- After 6 cycles of chemotherapy, approximately 3 weeks of radiation therapy will begin.
One month after completing radiation therapy, the patient will return to the clinic for
a physical exam and blood tests. One month later, the following evaluations will
occur: PET and CT scans; medical history; physical exam; routine blood tests.
- There will be follow-up visits every 3 months for two years after the study treatment
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the rate of complete response to therapy defined as resolution of PET avidity in all previously documented sites at the completion of chemotherapy.
Ann LaCasce, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana Farber Cancer Institute||Boston, Massachusetts 02115|