NCT00265928

Brief Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. 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. Giving bortezomib together with rituximab may be an effective treatment for non-Hodgkin's lymphoma. PURPOSE: This phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma, including Waldenstrom's macroglobulinemia.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_2 lymphoma

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2005

Completed
Last Updated

January 28, 2008

Status Verified

January 1, 2007

First QC Date

December 14, 2005

Last Update Submit

January 24, 2008

Conditions

Lymphoma

Keywords

extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuerecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomasplenic marginal zone lymphomarecurrent adult diffuse small cleaved cell lymphomanodal marginal zone B-cell lymphomaWaldenstrom's macroglobulinemia

Interventions

bortezomibDRUG
rituximabDRUG
antibody therapyPROCEDURE
biological therapyPROCEDURE
enzyme inhibitor therapyPROCEDURE
monoclonal antibody therapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL) including the following subtypes: * B-cell small lymphocytic lymphoma * Marginal zone lymphoma (extranodal, nodal, or splenic) * Grade 1-3 follicular lymphoma * Mantle cell lymphoma * Waldenstrom's macroglobulinemia * Bidimensionally measurable disease by CT scan with ≥ 1 lesion measuring \> 1.5 cm in a single dimension * Relapsed or refractory disease after prior antineoplastic therapy, meeting 1 of the following criteria: * No response to prior treatment * Relapsed disease after prior therapy * Confirmed CD20-positive disease by immunohistochemistry on biopsy specimen * Prior transformation allowed provided there is no evidence of aggressive histology on recent biopsy * No chronic lymphocytic lymphoma with absolute lymphocyte count \> 5,000/mm³ * No CNS involvement PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm\^3 (≥ 1,000/mm³ if due to extensive bone marrow involvement with NHL or splenomegaly) * Absolute lymphocyte count ≤ 5,000/mm³ (except mantle cell lymphoma with a leukemic phase) * Platelet count ≥ 50,000/mm\^3 * Bilirubin ≤ 2.0 mg/dL * AST and ALT ≤ 2.5 times upper limit of normal (ULN) (4 times ULN if liver involvement with NHL) * Creatinine ≤ 2.0 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile male and female patients must use effective contraception during study * No serious nonmalignant disease * No active infection * No peripheral neuropathy ≥ grade 2 within past 14 days * No myocardial infarction within the past 6 months * No New York Heart Association class III or IV heart failure * No uncontrolled angina pectoris * No severe uncontrolled ventricular arrhythmias * No EKG evidence of acute ischemia or active conduction system abnormalities * Any EKG abnormality must be documented as not medically relevant * No hypersensitivity to bortezomib, boron, or mannitol * No known anaphylaxis or immunoglobulin E-mediated hypersensitivity to murine proteins or any component of rituximab (including polysorbate 80 and sodium citrate dehydrate) * No known infection or exposure to HIV * No serious psychiatric or medical illness that would preclude study participation * No active hepatitis B infection * No other primary malignancy requiring active treatment * More than 4 weeks since prior significant traumatic injury PRIOR CONCURRENT THERAPY: * At least 3 weeks since prior and no concurrent radiotherapy * More than 4 weeks since prior major surgery or open biopsy * Other diagnostic surgery allowed * More than 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas) * At least 3 months since prior unconjugated monoclonal antibody therapy * At least 10 weeks since prior radioimmunoconjugates or toxin immunoconjugates (e.g., iodine I 131 tositumomab \[Bexxar\] or ibritumomab tiuxetan \[Zevalin\]) * More than 2 weeks since prior investigational agent * No prior bortezomib * No concurrent systemic corticosteroid at greater than the equivalent dose of 20 mg/day of prednisone, unless for treatment of allergic reactions to CT scan dye * No concurrent major surgery * No other immunosuppressive agents, unless for treatment of allergic reactions to CT scan dye * No other concurrent antilymphoma agents * No other concurrent investigational agent * Concurrent participation in another nontreatment study allowed if it does not interfere with participation in this study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Cancer Center at UV Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Non-HodgkinWaldenstrom Macroglobulinemia

Interventions

BortezomibRituximabImmunization, PassiveBiological TherapyAntibodies, Monoclonal

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAntibodies, Monoclonal, Murine-DerivedAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsImmunizationImmunotherapyImmunomodulationTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • John Densmore, MD

    University of Virginia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 14, 2005

First Posted

December 15, 2005

Last Updated

January 28, 2008

Record last verified: 2007-01

Locations

US(1)