Ph II CHOP+Velcade in Mediastinal LBCL | RxWiki

Ph II CHOP+Velcade in Mediastinal LBCL

Overview[ - collapse ][ - ]

Purpose	The main purpose of this study is to begin to collect information and try to learn whether or not VELCADE, when added to standard chemotherapy with CHOP/Rituxan, works in treating patients mediastinal large B-cell lymphoma. Recent research has shown that this type of lymphoma shares features with Hodgkin's lymphoma, including the importance of a particular pathway in the tumor cells called the NF-kB pathway. VELCADE works in part by blocking this pathway.
Condition	Non-Hodgkin's Lymphoma
Intervention	Drug: bortezomib Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Radiation: Radiation therapy
Phase	Phase 2
Sponsor	Dana-Farber Cancer Institute
Responsible Party	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier	NCT00361621
First Received	August 7, 2006
Last Updated	November 30, 2012
Last verified	October 2009

Tracking Information[ + expand ][ + ]

First Received Date	August 7, 2006
Last Updated Date	November 30, 2012
Start Date	July 2006
Estimated Primary Completion Date	May 2008
Current Primary Outcome Measures	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] [Designated as safety issue: No]
Current Secondary Outcome Measures	Assess toxicity [Time Frame: 1 year] [Designated as safety issue: Yes] evaluate event-free survival at 2 years [Time Frame: 2 years] [Designated as safety issue: No] evaluate overall survival at 2 years [Time Frame: 2 years] [Designated as safety issue: No] assess early PET restaging after 3 cycles of chemotherapy. [Time Frame: 1 year] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Ph II CHOP+Velcade in Mediastinal LBCL
Official Title	Phase II Study of CHOP/Rituxan Plus VELCADE in Mediastinal Large B-cell Lymphoma
Brief Summary	The main purpose of this study is to begin to collect information and try to learn whether or not VELCADE, when added to standard chemotherapy with CHOP/Rituxan, works in treating patients mediastinal large B-cell lymphoma. Recent research has shown that this type of lymphoma shares features with Hodgkin's lymphoma, including the importance of a particular pathway in the tumor cells called the NF-kB pathway. VELCADE works in part by blocking this pathway.
Detailed Description	- 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
Study Phase	Phase 2
Study Design	Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Non-Hodgkin's Lymphoma
Intervention	Drug: bortezomib Given intravenously on day 1 and day 4 of a 21-day cycle for 6 cycles Other Names: VelcadeDrug: Rituximab Given intravenously on day 1 of a 21-day cycle for 6 cycles Drug: Cyclophosphamide Given intravenously on day 1 of a 21-day cycle for 6 cycles Drug: Doxorubicin Given intravenously on day 1 of a 21-day cycle for 6 cycles Drug: Vincristine Given intravenously on day 1 of a 21-day cycle for 6 cycles Drug: Prednisone Taken orally on days 2, 3, 4 and 5 or a 21-day cycle for 6 cycles Radiation: Radiation therapy After 6 cycles of chemotherapy there will be 3 weeks of radiation therapy
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Terminated
Estimated Enrollment	3
Estimated Completion Date	May 2008
Estimated Primary Completion Date	November 2007
Eligibility Criteria	Inclusion Criteria: - Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. - Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. - Male subject agrees to use an acceptable method for contraception for the duration of the study. - Histologic Documentation: Histologically confirmed Primary Mediastinal Large B-cell Lymphoma with confirmatory immunoperoxidase stains including TRAF-1, and nuclear c-rel. All cases must be reviewed at Brigham and Women's Hospital. - Previously untreated patients with the exception of limited radiotherapy or steroids for SVC syndrome - Age > 18 years of age - Measurable Disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan. Exclusion Criteria: - Patient has a platelet count of < 100,000/uL within 14 days before enrollment. - Patient has an absolute neutrophil count of < 1500/uL within 14 days before enrollment. - Patient has a calculated or measured creatinine clearance of <30 mL/minute within 14 days before enrollment. - Patient has ³Grade 2 peripheral neuropathy within 14 days before enrollment. - Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant. - Patient has hypersensitivity to bortezomib, boron or mannitol. - Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum b-human chorionic gonadotropin (b-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. - Patient has received other investigational drugs with 14 days before enrollment - Serious medical or psychiatric illness likely to interfere with participation in this clinical study. - Patient has a cardiac ejection fraction < 50% by echocardiogram or MUGA scan
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00361621
Other Study ID Numbers	06-012
Has Data Monitoring Committee	Not Provided
Information Provided By	Dana-Farber Cancer Institute
Study Sponsor	Dana-Farber Cancer Institute
Collaborators	Brigham and Women's Hospital Millennium Pharmaceuticals, Inc.
Investigators	Principal Investigator: Ann LaCasce, MD Dana-Farber Cancer Institute
Verification Date	October 2009

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