Bortezomib and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

Status:

TERMINATED

Bortezomib and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

Lead Sponsor:

University of Virginia

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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. S...

Detailed Description

OBJECTIVES: Primary * Assess the safety and tolerability of bortezomib and rituximab in patients with relapsed or refractory, B-cell non-Hodgkin's lymphoma. * Determine the overall response rate (pa...

Eligibility Criteria

Inclusion

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

Exclusion

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT00265928

Last Update

January 28 2008

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)