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Bortezomib in Treating Patients With Mantle Cell Lymphoma
This study is ongoing, but not recruiting participants.
First Received: February 14, 2002   Last Updated: July 23, 2008   History of Changes
Sponsored by: National Cancer Institute of Canada
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00030875
  Purpose

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

PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have previously untreated or relapsed mantle cell lymphoma.


Condition Intervention Phase
Lymphoma
Drug: bortezomib
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Bortezomib
U.S. FDA Resources
Study Type: Interventional
Study Design: Active Control, Non-Randomized, Treatment
Official Title: A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Mantle Cell Lymphoma

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

Study Start Date: July 2002
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of bortezomib, in terms of response rate, in patients with previously untreated or relapsed mantle cell lymphoma.
  • Determine the toxicity of this drug in these patients.
  • Correlate suppression of 20S proteasome levels with toxicity of and response to this drug in these patients.
  • Determine the time to progression and response duration in patients treated with this drug.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 courses beyond documentation of CR. Patients with stable disease receive a maximum of 4 courses. Patients with partial response (PR) continue therapy until disease progression or for 2 courses beyond documentation of stable PR.

Patients are followed at 4 weeks and then every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 18-24 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed relapsed or untreated mantle cell lymphoma

    • No refractory disease defined as progression while on chemotherapy or within 1 month after completion of chemotherapy
  • At least 1 bidimensionally measurable disease site*

    • Lymph nodes at least 1.5 cm by 1.5 cm by spiral CT scan OR
    • Non-nodal lesions (e.g., skin lesion or nodules) at least 1 cm by 1 cm by MRI, CT scan, or physical exam NOTE: *Bone lesions are not considered bidimensionally measurable disease
  • No pre-existing ascites or pleural effusion
  • No known CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 75,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST or ALT no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • LVEF at least 45% by echocardiogram or MUGA

Pulmonary

  • No pre-existing shortness of breath greater than grade 1

Other:

  • No uncontrolled bacterial, fungal, or viral infections
  • No pre-existing edema greater than grade 1
  • No pre-existing neuropathy greater than grade 1
  • No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No other serious illness or medical condition that would preclude study compliance
  • No geographical conditions that would preclude study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Chemotherapy
  • Prior rituximab allowed
  • No prior radioactive monoclonal antibody therapy

Chemotherapy:

  • See Disease Characteristics
  • No prior high-dose chemotherapy with stem cell transplantation
  • No more than 2 prior systemic chemotherapy regimens

    • Same chemotherapy combination given for first-line and second-line therapy is considered 2 regimens
  • No prior flavopiridol
  • At least 6 weeks since prior chemotherapy
  • No concurrent cytotoxic chemotherapy

Endocrine therapy:

  • No concurrent corticosteroids

Radiotherapy:

  • No prior radiotherapy to 25% or more of functioning bone marrow
  • At least 4 weeks since prior radiotherapy (except low-dose nonmyelosuppressive radiotherapy) and recovered
  • No concurrent radiotherapy to the sole site of measurable disease

Surgery:

  • At least 2 weeks since prior major surgery

Other:

  • No prior investigational therapy
  • No other concurrent anticancer therapy
  • No other concurrent investigational anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030875

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Kingston Regional Cancer Centre
Kingston, Ontario, Canada, K7L 5P9
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H2W 1S6
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
National Cancer Institute of Canada
Investigators
Study Chair: Andrew R. Belch, MD Cross Cancer Institute at University of Alberta
  More Information

Additional Information:
Publications of Results:
Belch A, Kouroukis CT, Crump M: Phase II trial of bortezomib in mantle cell lymphoma. [Abstract] Blood 104(11): A-608, 2004.
Assouline S, Belch A, Sehn L, et al.: A phase II study of bortezomib in patients with mantle cell lymphoma. [Abstract] Blood 102 (11 Pt 1): A-3358, 2003.
Belch A, Kouroukis C, Crump M, Sehn L, Gascoyne R, Klasa R, Powers J, Wright J, Eisenhauer E. A phase II study of bortezomib in mantle cell lymphoma: the National Cancer Institute of Canada Clinical Trials Group trial IND.150. Ann Oncol. 2007 Jan;18(1):116-21. Epub 2006 Sep 13.

Study ID Numbers: CDR0000069207, CAN-NCIC-IND150
Study First Received: February 14, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00030875     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
recurrent mantle cell lymphoma
stage I mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, Mantle-Cell
Bortezomib
Mantle Cell Lymphoma
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Recurrence
Protease Inhibitors

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Lymphoma, Mantle-Cell
Bortezomib
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on March 16, 2009