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Bortezomib in Treating Patients With Diffuse Large B-Cell Lymphoma That Is Refractory To Chemotherapy

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bortezomib
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent adult diffuse large cell lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Outcomes

Primary Outcome Measures

Overall response rate (combined complete response and partial response)

Secondary Outcome Measures

Safety
Tolerability
Time to disease progression
Possible mechanism of resistance

Full Information

First Posted
August 6, 2003
Last Updated
January 7, 2013
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00066508
Brief Title
Bortezomib in Treating Patients With Diffuse Large B-Cell Lymphoma That Is Refractory To Chemotherapy
Official Title
A Phase II Study Of PS-341 (VELCADE) In Chemotherapy-Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent adult diffuse large cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bortezomib
Primary Outcome Measure Information:
Title
Overall response rate (combined complete response and partial response)
Secondary Outcome Measure Information:
Title
Safety
Title
Tolerability
Title
Time to disease progression
Title
Possible mechanism of resistance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven De Vos, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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Bortezomib in Treating Patients With Diffuse Large B-Cell Lymphoma That Is Refractory To Chemotherapy

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