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

NCT ID: NCT00066508

Last Updated: 2013-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31

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.

Conditions

Lymphoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

bortezomib

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Sven De Vos, MD

Role: STUDY_CHAIR

Jonsson Comprehensive Cancer Center

Locations

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

Countries

United States

Other Identifiers

UCLA-0301090

Identifier Type: -

Identifier Source: secondary_id

CDR0000316254

Identifier Type: -

Identifier Source: org_study_id