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Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: National Cancer Institute of Canada
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00045695
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: bortezomib
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Bortezomib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Waldenstrom's Macroglobulinemia

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045695

Locations
United States, Illinois
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
United States, Pennsylvania
Abramson Cancer Center at the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Canada, Saskatchewan
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
National Cancer Institute of Canada
Eastern Cooperative Oncology Group
Investigators
Study Chair: Christine I. Chen, MD Princess Margaret Hospital, Canada
Investigator: Edward A. Stadtmauer, MD University of Pennsylvania
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Chen CI, Kouroukis CT, White D, Voralia M, Stadtmauer E, Stewart AK, Wright JJ, Powers J, Walsh W, Eisenhauer E. 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 Mar 12; [Epub ahead of print]
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.

Study ID Numbers: CDR0000257042, CAN-NCIC-IND152, ECOG-JI152, NCI-NCIC-152
Study First Received: September 6, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00045695  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
Waldenstrom macroglobulinemia

Study placed in the following topic categories:
Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Bortezomib
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Lymphatic Diseases
Waldenstrom Macroglobulinemia
Hemorrhagic Disorders
Waldenstrom macroglobulinemia
Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009