Expired Study
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Los Angeles, California 90095


Purpose:

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have diffuse large B-cell lymphoma that is refractory to previous chemotherapy.


Study summary:

OBJECTIVES: - Determine the overall response rate in patients with chemotherapy-refractory diffuse large B-cell lymphoma treated with bortezomib. - Determine the safety and tolerability of this drug in these patients. - Determine the time to disease progression in patients treated with this drug. - Determine the possible mechanism of resistance to this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 20 days and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed diffuse large B-cell lymphoma, meeting criteria for 1 of the following: - Relapsed after prior high-dose chemotherapy with stem cell support - Relapsed after prior chemotherapy, including at least 1 prior standard non-Hodgkin's chemotherapy regimen, but not a candidate for high-dose chemotherapy with stem cell support - Measurable disease - At least 1 bidimensionally measurable lesion at least 1.5 cm by CT scan - No primary or secondary CNS lymphoma - No HIV-related lymphoma - No known brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 3 months Hematopoietic - Hemoglobin at least 9 g/dL - Absolute neutrophil count at least 1,000/mm^3 - No colony-stimulating factors within 4 weeks before obtaining this result - Platelet count at least 50,000/mm^3 - No platelet transfusion within 4 weeks before obtaining this result Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN - No active hepatitis B or C viral infection Renal - Creatinine no greater than 2 times ULN OR - Creatinine clearance at least 60 mL/min Cardiovascular - No myocardial infarction within the past 6 months - No evidence of acute ischemia or new conduction system abnormalities on EKG - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Sodium greater than 130 mEq/L - HIV negative - No ongoing or active infection - No other concurrent uncontrolled illness that would preclude study participation - No psychiatric illness or social situation that would preclude study compliance - No prior allergic reaction attributable to compounds of similar chemical or biological composition to bortezomib PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - See Chemotherapy - At least 4 weeks since prior immunotherapy Chemotherapy - See Disease Characteristics - More than 4 weeks since prior chemotherapy - More than 12 weeks since prior high-dose chemotherapy with hematopoietic stem cell support Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - More than 4 weeks since prior major surgery unless fully recovered Other - Recovered from prior therapy - No other concurrent investigational agents - No other concurrent investigational or commercial agents or therapies to treat the malignancy


NCT ID:

NCT00066508


Primary Contact:

Study Chair
Sven De Vos, MD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

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