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

Sponsor:	University of Miami Sylvester Comprehensive Cancer Center
Information provided by:	University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00772668

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	Biological: rituximab Drug: bortezomib Drug: cyclophosphamide Drug: prednisone

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Cyclophosphamide Prednisone Rituximab Bortezomib

U.S. FDA Resources

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) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival as assessed by RECIST criteria [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Safety and tolerance to rituximab, cyclophosphamide, bortezomib, and prednisone [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	September 2008
Estimated Primary Completion Date:	September 2015 (Final data collection date for primary outcome measure)

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

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

Locations

United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami	Recruiting
Miami, Florida, United States, 33136
Contact: University of Miami Sylvester Comprehensive Cancer Center Clin 866-574-5124 Sylvester@emergingmed.com

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

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Miami Sylvester Comprehensive Cancer Center ( Denise Pereira, MD )
Study ID Numbers:	EPROST-20070963, SCCC-2006120
Study First Received:	October 12, 2008
Last Updated:	January 11, 2010
ClinicalTrials.gov Identifier:	NCT00772668 History of Changes
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, Non-Hodgkin
Lymphoma, Follicular
Anti-Inflammatory Agents
Prednisone
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cyclophosphamide
Hormones
Therapeutic Uses
Alkylating Agents
Immunoproliferative Disorders

Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Rituximab
Bortezomib
Enzyme Inhibitors
Immunosuppressive Agents
Glucocorticoids
Pharmacologic Actions
Protease Inhibitors
Lymphatic Diseases
Neoplasms
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on February 08, 2010