Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI UCLA-0301090 NCT00066508

Objectives

1. Determine the overall response rate in patients with chemotherapy-refractory diffuse large B-cell lymphoma treated with bortezomib.
2. Determine the safety and tolerability of this drug in these patients.
3. Determine the time to disease progression in patients treated with this drug.
4. Determine the possible mechanism of resistance to this drug in these patients.

Entry 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

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

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/mm³
  • No colony-stimulating factors within 4 weeks before obtaining this result
• Platelet count at least 50,000/mm³
  • 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

Expected Enrollment

A total of 22-40 patients will be accrued for this study.

Outcomes

Overall response rate (combined complete response and partial response)

Safety
Tolerability
Time to disease progression
Possible mechanism of resistance

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.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Sven De Vos, MD, Protocol chair		Ph: 310-825-4796; 888-798-0719 Email: devos@mednet.ucla.edu

Registry Information
Official Title		A Phase II Study Of PS-341 (VELCADE) In Chemotherapy-Refractory Diffuse large B-Cell Lymphoma (DLBCL)
Trial Start Date		2003-05-23
Registered in ClinicalTrials.gov		NCT00066508
Date Submitted to PDQ		2003-06-18
Information Last Verified		2005-09-06
NCI Grant/Contract Number		P30-CA16042

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