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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bortezomib

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