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Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia

A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Waldenstrom's Macroglobulinemia

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00045695
Enrollment
27
Registered
2003-01-27
Start date
2002-08-31
Completion date
2009-12-31
Last updated
2013-05-17

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

Conditions

Lymphoma

Keywords

Waldenstrom macroglobulinemia

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.

Interventions

DRUGbortezomib

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Eastern Cooperative Oncology Group
CollaboratorNETWORK
NCIC Clinical Trials Group
Lead SponsorNETWORK

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Response rate4 yearsTo 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

Secondary

MeasureTime frameDescription
Toxicity4 yearsTo assess the toxicity of PS-341 in patients with Waldenström's Macroglobulinemia as well as time to progression, stable disease duration and, if responses are observed, response duration.
Cytogenetics and genome profiling4 yearsTo assess bone marrow and peripheral blood for cytogenetics and genome profiling by microarray in patients with Waldenstrom's macroglobulinemia.

Countries

Canada, United States

Outcome results

None listed

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