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LymphomaPhase 2NCT00045695

Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia

A Phase 2 study testing bortezomib in people with Lymphoma, run by NCIC Clinical Trials Group at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
bortezomib
Type of treatment
Injection or infusion
How many people
27 participants
Where
12 sitesin 2 countries
Study dates
Aug 2002to Dec 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

Canada10 sites

  • Tom Baker Cancer Centre - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

United States2 sites

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • Abramson Cancer Center at the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

Other trials in United States

About this study

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

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.

Read the 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
Being tested
bortezomib
Keywords
Waldenstrom macroglobulinemia
Medical subject headings
Lymphoma, Waldenstrom Macroglobulinemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bortezomibDrug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 years

Secondary outcomes (2)

  1. Toxicity

    To 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.

    Measured: 4 years

  2. Cytogenetics and genome profiling

    To assess bone marrow and peripheral blood for cytogenetics and genome profiling by microarray in patients with Waldenstrom's macroglobulinemia.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 2002
  3. Primary completionMar 2006
  4. Study completionDec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00045695
Sponsor's protocol ID
I152
Other IDs
CAN-NCIC-IND152, ECOG-JI152, NCI-NCIC-152, CDR0000257042
Status last verified
Sep 2011
First submitted
6 Sep 2002
Last updated
17 May 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17353550

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bortezomib in people with Lymphoma, run by NCIC Clinical Trials Group at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00045695, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2013.

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