Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Patients With Stage III/IV FL or MZL

Stopped early · Not applicable

Conditions studied: Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma

In brief

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 or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving rituximab together with cyclophosphamide, bortezomib, and prednisone may kill more cancer cells. PURPOSE: This clinical trial is studying how well giving rituximab together with cyclophosphamide, bortezomib, and prednisone works as first-line therapy in treating patients with stage III or stage IV follicular lymphoma or marginal zone lymphoma.

Key facts

Study ID: NCT00772668
Run by: University of Miami
People needed: 3
Starts: 2009-09-25
Expected to finish: 2011-02-01
Last updated by the study team: 2017-12-11

Who can join

Age: 17 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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.

You may not qualify if…

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.

Where it is running

University of Miami Sylvester Comprehensive Cancer Center - Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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