Status:
TERMINATED
Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Patients With Stage III/IV FL or MZL
Lead Sponsor:
University of Miami
Conditions:
Lymphoma
Follicular Lymphoma
Eligibility:
All Genders
17-120 years
Phase:
NA
Brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them o...
Detailed Description
OUTLINE: * Induction therapy: Patients receive rituximab IV and cyclophosphamide IV over 30 minutes on day 1, bortezomib IV on days 1 and 8, and oral prednisone once daily on days 1-5. Treatment repe...
Eligibility Criteria
Inclusion
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Histologically confirmed, untreated follicular lymphoma (FL) grade I, II or marginal zone lymphoma (MZL) Stage III or IV
- Presence of measurable or evaluable disease
- Age \>17 years old
- Patients must have normal organ and marrow function as defined below, within 14 days of enrollment:
- Serum bilirubin \< 2.0 mg/dL
- serum creatinine \< 2 mg/dL unless due to lymphoma
- Absolute Neutrophil Count (ANC) \>1000/mm3
- Platelets \>100,000/mm3 unless due to lymphoma
- Aspartate Transaminase (AST), Alanine Aminotransferase (ALT) and Alkaline phosphatase \< 3x the upper limit of normal
- Eastern Cooperative Oncology Group (ECOG) performance status of 1, 2, 3
- No prior therapy for the FL or MZL including chemotherapy, single agent rituximab and radiation therapy
- Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., 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.
- Exclusion Criteria
- Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 5), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Patient has hypersensitivity to boron or mannitol.
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-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.
- History of HIV infection (testing not required)
- Concurrent or previous malignancy whose prognosis is poor (\< 90% probability of survival at 5 years) or those who are actively being treated for a second malignancy.
Exclusion
Key Trial Info
Start Date :
September 25 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00772668
Start Date
September 25 2009
End Date
February 1 2011
Last Update
December 11 2017
Active Locations (1)
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1
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136