Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia

NCT00045695 | Completed Phase 2

• 5 other identifiers: I152CAN-NCIC-IND152ECOG-JI152NCI-NCIC-152CDR0000257042
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 12

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.

Conditions

Lymphoma

Keywords

Waldenstrom macroglobulinemia

Outcome Measures

Primary Outcomes (1)

• Response rate

  To assess the efficacy (response rate) of PS-341 given as a bolus intravenous injection twice weekly for two out of every 3 weeks in the treatment of a population of patients with previously untreated or relapsed Waldenström's Macroglobulinemia

  4 years

Secondary Outcomes (2)

• Toxicity

  4 years

• Cytogenetics and genome profiling

  4 years

Interventions

bortezomib DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• National Cancer Institute (NCI): collaborator
• Eastern Cooperative Oncology Group: collaborator

Study Sites (12)

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, 60521, United States

Location

Abramson Cancer Center at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (2)

• 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.

  PMID: 17353550 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Lymphoma; Waldenstrom Macroglobulinemia

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Christine I. Chen, MD

  Princess Margaret Hospital, Canada

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2002
• First Posted: January 27, 2003
• Study Start: August 1, 2002
• Primary Completion: March 1, 2006
• Study Completion: December 1, 2009
• Last Updated: May 17, 2013

Record last verified: 2011-09

Locations

US (2); CA (10)