Bortezomib and Rituximab in Treating Patients With Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Giving bortezomib together with rituximab may kill more cancer cells.

PURPOSE: This randomized phase II trial is studying how well giving bortezomib together with rituximab works in treating patients with relapsed or refractory non-Hodgkin's lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bortezomib; Rituximab

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of indolent B-cell non-Hodgkin's lymphoma of 1 of the following subtypes:

• Follicular (grade 1, 2, or 3)

• Marginal zone (extranodal, nodal, or splenic)

• CD20-positive disease

• Relapsed or progressive disease after prior anti-neoplastic therapy, as indicated by 1 of the following:

• New lesions

• Objective evidence of progression of existing lesions

• Complete response ≥ 6 months in duration after prior rituximab therapy* NOTE: *For patients who were previously treated with a regimen that included rituximab

• At least 1 measurable lymph node mass > 1.5 cm in 2 perpendicular dimensions that has not been irradiated OR that has progressed since prior radiotherapy

• No active CNS lymphoma

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 50-100% OR

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,000/mm^3

• Platelet count ≥ 50,000/mm^3

Hepatic

• AST and ALT ≤ 3 times upper limit of normal (ULN)

• Bilirubin ≤ 2 times ULN

Renal

• Creatinine ≤ 2 mg/dL OR

• Creatinine clearance ≥ 30 mL/min

Immunologic

• No known anaphylaxis or immunoglobulin E-mediated hypersensitivity to murine proteins or to any component of rituximab, including polysorbate 80 and sodium citrate dihydrate

• No active systemic infection requiring treatment

• No history of allergic reaction attributable to compounds containing boron or mannitol

Other

• No peripheral neuropathy or neuropathic pain ≥ grade 2

• No other malignancy within the past 5 years except completely resected basal cell or squamous cell skin cancer or an in situ malignancy

• Previously diagnosed prostate cancer allowed provided the following criteria are met:

• T1-2a, N0, M0 disease AND Gleason score ≤ 7 AND prostate specific antigen (PSA) ≤ 10 ng/mL before initial therapy

• Treated with definitive curative therapy (i.e., prostatectomy or radiotherapy) within the past 2 years

• No clinical evidence of prostate cancer AND undetectable PSA (for prostatectomy patients) or PSA < 1 ng/mL (for patients who did not undergo prostatectomy)

• No serious medical or psychiatric illness that would preclude study participation

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

• More than 10 weeks since prior radioimmunoconjugates or toxin immunoconjugates (e.g., ibritumomab tiuxetan or iodine I 131 tositumomab)

• More than 4 weeks since prior rituximab, alemtuzumab, or other unconjugated therapeutic antibody

• No concurrent prophylactic bone marrow growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or epoetin alfa) during course 1 of study therapy

Chemotherapy

• More than 6 weeks since prior nitrosoureas

• No concurrent cisplatin

Endocrine therapy

• No concurrent corticosteroids (e.g., dexamethasone) except prednisone ≤ 15 mg/day or equivalent for adrenal insufficiency

Radiotherapy

• See Disease Characteristics

• See Biologic therapy

• More than 3 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery

• More than 2 weeks since prior major surgery

Other

• Recovered from all prior therapy

• No prior bortezomib

• More than 3 weeks since prior antineoplastic therapy

• More than 3 weeks since prior experimental therapy

• No other concurrent antineoplastic therapy

• No other concurrent investigational agents

• Concurrent participation in a non-treatment study allowed provided it does not interfere with participation in this study