Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia

NCT ID: NCT00045695

Last Updated: 2013-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31
• Study Completion Date: 2009-12-31

Brief Summary

RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have untreated or relapsed Waldenstrom's macroglobulinemia.

Detailed Description

OBJECTIVES:

• Determine the efficacy of bortezomib, in terms of response rate, in patients with previously untreated or relapsed Waldenstrom's macroglobulinemia.
• Determine the toxicity of this drug in these patients.
• Determine the time to progression, stable disease duration, and response duration in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks. Patients with complete or partial response or stable disease are followed every 3 months thereafter.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 1.5-2 years.

Conditions

Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

bortezomib

PS-341 bolus intravenous injection twice weekly\* for 2 out of every 3 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of Waldenstrom's macroglobulinemia confirmed by immunofixation or immunoelectrophoresis

• Newly diagnosed or untreated with IgM ≥ 20 g/L OR
• Previously treated with IgM ≥ 5 g/L
• Non-refractory, defined as no disease progression during prior therapy or within 4 weeks of the last dose of most recent prior therapy (12 weeks for rituximab)
• Must have 1 or more of the following:

• Symptomatic lymphadenopathy
• Hepatomegaly and/or splenomegaly
• Anemia (i.e., hemoglobin < 11.0 g/dL)
• Hyperviscosity syndrome
• No other lymphoproliferative disease including transformed aggressive lymphoma

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• See Disease Characteristics
• Absolute granulocyte count ≥ 1,000/mm^3
• Platelet count ≥ 50,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• AST or ALT ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Other

• No uncontrolled bacterial, fungal, or viral infection
• No pre-existing sensory or motor neurotoxicity grade 2 or greater
• No other prior malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor for which patient has been disease free for at least 5 years
• No other serious illness or medical condition that would preclude study participation
• No unreasonable geographical limitations
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Chemotherapy
• See Disease Characteristics
• At least 12 weeks since prior rituximab (for patients who have progressed)
• At least 24 weeks since prior rituximab (for patients who have not progressed)
• No prior high-dose chemotherapy and stem cell transplantation
• No prior radioactive monoclonal antibodies

Chemotherapy

• See Disease Characteristics
• See Biologic therapy
• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• No more than 2 prior chemotherapy regimens

• The same chemotherapy combination given for first-line and second-line therapy is considered 2 regimens
• Single-agent rituximab not considered 1 prior regimen
• No concurrent cytotoxic chemotherapy

Endocrine therapy

• No concurrent corticosteroids

Radiotherapy

• At least 4 weeks since prior radiotherapy (except for low-dose, non- myelosuppressive radiotherapy) and recovered
• No prior radiotherapy to more than 25% of bone marrow

Surgery

• At least 4 weeks since prior major surgery

Other

• At least 4 weeks since prior plasmapheresis
• At least 4 weeks since prior investigational anticancer therapy
• No other concurrent investigational anticancer agents or therapies

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Eastern Cooperative Oncology Group

NETWORK

Sponsor Role: collaborator

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine I. Chen, MD

Role: STUDY_CHAIR

Princess Margaret Hospital, Canada

Locations

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, United States

Abramson Cancer Center at the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, Canada

Cross Cancer Institute

Edmonton, Alberta, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, Canada

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, Canada

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Countries

United States; Canada

References

Chen CI, Kouroukis CT, White D, Voralia M, Stadtmauer E, Stewart AK, Wright JJ, Powers J, Walsh W, Eisenhauer E; National Cancer Institute of Canada Clinical Trials Group. Bortezomib is active in patients with untreated or relapsed Waldenstrom's macroglobulinemia: a phase II study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 Apr 20;25(12):1570-5. doi: 10.1200/JCO.2006.07.8659. Epub 2007 Mar 12.

Reference Type: RESULT

PMID: 17353550 (View on PubMed)

Chen CI, White Darrell, Kouroukis TC, et al.: Antitumor activity of bortezomib (PS-341; Velcade) in a phase II study of patients with previously untreated or treated Waldenstrom's macroglobulinemia (WM). [Abstract] Blood 104 (11): A-3278, 2004.

Reference Type: RESULT

Other Identifiers

CAN-NCIC-IND152

Identifier Type: -

Identifier Source: secondary_id

ECOG-JI152

Identifier Type: -

Identifier Source: secondary_id

NCI-NCIC-152

Identifier Type: -

Identifier Source: secondary_id

CDR0000257042

Identifier Type: OTHER

Identifier Source: secondary_id

I152

Identifier Type: -

Identifier Source: org_study_id