Lymphoma
Conditions
Keywords
recurrent adult diffuse large cell lymphoma
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (combined complete response and partial response) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety | — |
| Tolerability | — |
| Time to disease progression | — |
| Possible mechanism of resistance | — |
Countries
United States