Ph II CHOP+Velcade in Mediastinal LBCL
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|ClinicalTrials.gov Identifier: NCT00361621|
Recruitment Status : Terminated (Closed due to slow accrual)
First Posted : August 8, 2006
Last Update Posted : December 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Non-Hodgkin's Lymphoma||Drug: bortezomib Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Radiation: Radiation therapy||Phase 2|
- 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 is completed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of CHOP/Rituxan Plus VELCADE in Mediastinal Large B-cell Lymphoma|
|Study Start Date :||July 2006|
|Primary Completion Date :||November 2007|
|Study Completion Date :||May 2008|
- 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. [ Time Frame: 1 year ]
- Assess toxicity [ Time Frame: 1 year ]
- evaluate event-free survival at 2 years [ Time Frame: 2 years ]
- evaluate overall survival at 2 years [ Time Frame: 2 years ]
- assess early PET restaging after 3 cycles of chemotherapy. [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00361621
|United States, Massachusetts|
|Dana Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Ann LaCasce, MD||Dana-Farber Cancer Institute|