NCT00066508CompletedPhase 2
A Phase II Study Of PS-341 (VELCADE) In Chemotherapy-Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Jonsson Comprehensive Cancer Center2 sites in 1 country7 target enrollmentStarted: May 1, 2003Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Overall response rate (combined complete response and partial response)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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
- •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
- •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
- •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
- +10 more not shown
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Overall response rate (combined complete response and partial response)
Secondary Outcomes
- Safety
- Tolerability
- Time to disease progression
- Possible mechanism of resistance
Investigators
Study Sites (2)
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