Overview

This trial is active, not recruiting.

Condition lymphoma
Treatments rituximab, bortezomib, cyclophosphamide, dexamethasone, questionnaire administration, quality-of-life assessment
Phase phase 2
Targets CD20, proteasome
Sponsor Mayo Clinic
Collaborator National Cancer Institute (NCI)
Start date October 2008
End date November 2013
Trial size 36 participants
Trial identifier NCT00711828, 08-001490, MC0883, P30CA015083

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. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab and bortezomib together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab and cyclophosphamide together with bortezomib and dexamethasone works in treating patients with relapsed or refractory low-grade follicular lymphoma, Waldenstrom macroglobulinemia, or mantle cell lymphoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Proportion of responses (complete response or partial response)
time frame:

Secondary Outcomes

Measure
Overall survival
time frame:
Progression-free survival
time frame:
Duration of response
time frame:
Time to treatment failure
time frame:
Adverse events
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed relapsed or refractory follicular lymphoma (grade I or II), mantle cell lymphoma (MCL), or lymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia [WM]) - MCL confirmed by cyclin D1 staining or fluorescent in situ hybridization [t(11;14)] - Measurable disease, defined as lymph nodes ≥ 2.0 cm in at least one dimension by CT scan, PET/CT scan, or MRI - Patients with WM without lymphadenopathy must have > 10% lymphocytes, lymphoplasmacytic cells, or plasma cells on a bone marrow aspirate/biopsy AND quantitative IgM ≥ 400 mg/dL PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Life expectancy > 3 months - ANC ≥ 1,200/mm^3 - Platelet count ≥ 75,000/mm^3 - Hemoglobin ≥ 8.0 g/dL - Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin ≤ 2.0 mg/dL - Alkaline phosphatase ≤ 3 times ULN - AST ≤ 3 times ULN - Creatinine ≤ 1.5 times ULN - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No comorbid systemic illness or other severe concurrent disease that, in the judgment of the investigator, would exclude the patient from participating in this study or would interfere significantly with the proper assessment of safety and adverse events of the prescribed study regimen - No known HIV positivity - No concurrent uncontrolled illness including, but not limited to, any of the following: - Ongoing or active infection - Symptomatic congestive heart failure - Unstable or uncontrolled angina pectoris - Cardiac arrhythmias, including severe uncontrolled ventricular arrhythmias - Psychiatric illness/social situation that would preclude compliance with study requirements - No hypersensitivity to bortezomib, boron, or mannitol - No myocardial infarction within the past 6 months - No NYHA class III-IV heart failure - No evidence of acute ischemia by ECG - No active conduction system abnormalities - No other malignancy within the past 3 years, except for the following: - Completely resected basal cell or squamous cell carcinoma of the skin - In situ malignancy - Curatively treated prostate cancer deemed to be at low risk PRIOR CONCURRENT THERAPY: - More than 14 days since prior investigational drugs - At least 4 weeks since prior anticancer therapy, including radiotherapy, hormonal therapy, or surgery - No other concurrent investigational agents as treatment for the primary malignancy - No concurrent therapy for other malignancies, except hormonal therapy

Additional Information

Official title A Phase 2 Clinical Trial of Rituximab, Cyclophosphamide, Bortezomib (VELCADE®), and Dexamethasone (R-CyBor-D) in Relapsed Low Grade and Mantle Cell Lymphoma
Principal investigator Thomas E. Witzig, M.D.
Description OBJECTIVES: Primary - To assess tumor response in patients with relapsed or refractory low-grade follicular lymphoma (grade I or II), mantle cell lymphoma, or lymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia) treated with rituximab, cyclophosphamide, bortezomib, and dexamethasone. Secondary - To evaluate overall survival, progression-free survival, duration of response, and time to treatment failure in patients treated with this regimen. - To describe the adverse event profile (as assessed by NCI CTCAE version 3.0) of this regimen in these patients. - To evaluate the quality of life, in terms of patient-reported neurotoxicity, in patients treated with this regimen. OUTLINE: Patients receive rituximab IV on day 1, bortezomib IV on days 1, 4, 8, and 11, and oral cyclophosphamide and oral dexamethasone on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients complete a quality of life questionnaire (FACT/GOG neurotoxicity questionnaire, version 4.0) at baseline, on day 1 of courses 3, 6, and 9, and at the completion of study treatment. After completion of study treatment, patients are followed every 3-6 months for up to 5 years.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Mayo Clinic.