Status:
TERMINATED
Ph II CHOP+Velcade in Mediastinal LBCL
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Millennium Pharmaceuticals, Inc.
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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...
Eligibility Criteria
Inclusion
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00361621
Start Date
July 1 2006
End Date
May 1 2008
Last Update
December 3 2012
Active Locations (1)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115