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Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Treating Patients With Stage III or Stage IV Follicular Lymphoma or Marginal Zone Lymphoma

This study has been terminated.
(Funding)
Sponsor:
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00772668
First received: October 12, 2008
Last updated: July 25, 2014
Last verified: August 2013
  Purpose

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.


Condition Intervention
Lymphoma
Drug: Rituximab
Drug: Bortezomib
Drug: Cyclophosphamide
Drug: Prednisone

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of RCVELP as First Line Therapy for Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL)

Resource links provided by NLM:


Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:

Primary Outcome Measures:
  • Overall Response Rate, According to the International Workshop Criteria (IWC) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free Survival as Assessed by RECIST Criteria [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Safety and Tolerance to Rituximab, Cyclophosphamide, Bortezomib, and Prednisone [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: September 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RCVELP Drug: Rituximab
375 mg/m2 IV infusion at 50 mg/hr on Day 1 of every 21 days cycle for 8 cycles
Other Name: Rituxan
Drug: Bortezomib
1.6 mg/m2 IV push over 3-5 seconds on Days 1 and 8 of every 21 days cycle for 8 cycles
Other Name: Velcade
Drug: Cyclophosphamide
750 mg/m2 IVPB over 30 minuntes on Day 1 of every 21 day cycle for 8 cycles
Other Name: Cytoxan
Drug: Prednisone
100 mg PO daily on Days 1-5 of every 21 day cycle for 8 cycles

Detailed Description:

OBJECTIVES:

Primary

  • To determine the overall response rate, in terms of complete response (CR), unconfirmed CR, and partial response, in patients with follicular lymphoma or marginal zone lymphoma treated with rituximab, cyclophosphamide, bortezomib, and prednisone (R-CVelP) as first line of treatment.

Secondary

  • To determine progression-free survival of patients treated with this regimen.
  • To determine overall survival of patients treated with this regimen.
  • To determine the safety and tolerance to R-CVelP in these patients.

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed grade 1 or 2 follicular lymphoma (FL) or marginal zone lymphoma (MZL)

    • Stage III or IV disease
  • Measurable or evaluable disease
  • Previously untreated disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 1-3
  • ANC > 1,000/mm³
  • Platelet count > 100,000/mm³ (unless due to lymphoma)
  • Bilirubin < 2.0 mg/dL
  • Creatinine < 2 mg/dL (unless due to lymphoma)
  • AST, ALT, and alkaline phosphatase < 3 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No myocardial infarction within the past 6 months
  • No NYHA class III-IV heart failure
  • No uncontrolled angina
  • No severe uncontrolled ventricular arrhythmias
  • No ECG evidence of acute ischemia or active conductive system abnormalities
  • No hypersensitivity to boron or mannitol
  • No serious medical or psychiatric illness likely to interfere with participation in this clinical study
  • No history of HIV infection
  • No concurrent or previous malignancy with poor prognosis (< 90% probability of survival at 5 years) or actively treated for a second malignancy
  • No peripheral neuropathy ≥ grade 2 within the past 14 days

PRIOR CONCURRENT THERAPY:

  • No prior therapy for this disease including chemotherapy, single-agent rituximab, or radiotherapy
  • No other concurrent anticancer therapy including chemotherapy, radiation, hormonal treatment, or immunotherapy
  • At least 14 days since prior and no other concurrent investigational drugs
  • No concurrent participation in another clinical study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772668

Locations
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami Sylvester Comprehensive Cancer Center
Investigators
Study Chair: Denise Pereira, MD University of Miami Sylvester Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00772668     History of Changes
Other Study ID Numbers: UMIAMI-20070963, SCCC-2006120
Study First Received: October 12, 2008
Results First Received: January 18, 2013
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Follicular
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Bortezomib
Cyclophosphamide
Prednisone
Rituximab
Alkylating Agents
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014