Bortezomib in Treating Patients With Mantle Cell Lymphoma

This study has been completed.
Sponsor:
Information provided by:
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00030875
First received: February 14, 2002
Last updated: November 7, 2010
Last verified: March 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Mantle Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Study Start Date: July 2002
Study Completion Date: December 2009
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Kingston Regional Cancer Centre
Kingston, Ontario, Canada, K7L 5P9
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
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
McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Andrew R. Belch, MD Cross Cancer Institute at University of Alberta
  More Information

Additional Information:
Publications:
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.

ClinicalTrials.gov Identifier: NCT00030875     History of Changes
Other Study ID Numbers: I150, CAN-NCIC-IND150, CDR0000069207
Study First Received: February 14, 2002
Last Updated: November 7, 2010
Health Authority: United States: Federal Government

Keywords provided by NCIC Clinical Trials Group:
stage I mantle cell lymphoma
contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014