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

NCT ID: NCT00772668

Last Updated: 2017-12-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-25
• Study Completion Date: 2011-02-28

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 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.

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 repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance therapy.
• Maintenance therapy: Patients receive rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Conditions

Lymphoma; Follicular Lymphoma; Marginal Zone Lymphoma

Keywords

stage III grade 1 follicular lymphoma; stage IV grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage III marginal zone lymphoma; stage IV marginal zone lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RCVELP

Rituximab, Cyclophosphamide, Bortezomib, Prednisone (RCVELP):

• Rituximab

• Induction: 375 mg/m2 IV infusion on Day 1 of every 21 days cycle for 8 cycles
• Maintenance: 375/m2 Days 1, 8, 15, 22 every 6 months for up to 4 cycles
• Cyclophosphamide: 750 mg/m2 intravenous piggyback (IVPB) on Day 1 of every 21 day cycle for 8 cycles
• Bortezomib: 1.6 mg/m2 IV push on Days 1 and 8 of every 21 days cycle for 8 cycles
• Prednisone: 100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

Administered intravenously during induction and maintenance therapy per protocol.

Bortezomib

Intervention Type: DRUG

Administered intravenously per protocol.

Cyclophosphamide

Intervention Type: DRUG

Administered intravenously per protocol.

Prednisone

Intervention Type: DRUG

Administered orally (PO) per protocol.

Interventions

Rituximab

Administered intravenously during induction and maintenance therapy per protocol.

Intervention Type: DRUG

Bortezomib

Administered intravenously per protocol.

Intervention Type: DRUG

Cyclophosphamide

Administered intravenously per protocol.

Intervention Type: DRUG

Prednisone

Administered orally (PO) per protocol.

Intervention Type: DRUG

Other Intervention Names

Rituxan; Velcade; Cytoxan; Deltasone

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.
• 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.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Denise Pereira

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Denise Pereira, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami Sylvester Comprehensive Cancer Center

Locations

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

SCCC-2006120

Identifier Type: OTHER

Identifier Source: secondary_id

20070963

Identifier Type: -

Identifier Source: org_study_id