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

A Phase II Study Of PS-341 (VELCADE) In Chemotherapy-Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00066508
Enrollment
7
Registered
2003-08-07
Start date
2003-05-31
Completion date
Unknown
Last updated
2013-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

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

DRUGbortezomib

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Jonsson Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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: 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

MeasureTime frame
Overall response rate (combined complete response and partial response)

Secondary

MeasureTime frame
Safety
Tolerability
Time to disease progression
Possible mechanism of resistance

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026