Status:
COMPLETED
Bortezomib and Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
Lead Sponsor:
Jonsson Comprehensive Cancer Center
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 the enzymes necessary for their growth. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or de...
Detailed Description
OBJECTIVES: Primary * Determine the response rate (complete response \[CR\], CR-unconfirmed \[CRu\], and partial response \[PR\]) in patients with relapsed or refractory indolent B-cell non-Hodgkin'...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00093769
Start Date
August 1 2004
Last Update
October 4 2012
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095