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Bortezomib in Treating Patients With Mantle Cell Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
bortezomib
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cross Cancer Institute
  • British Columbia Cancer Agency
  • CancerCare Manitoba
  • Margaret and Charles Juravinski Cancer Centre
  • Kingston Regional Cancer Centre
  • Cancer Care Ontario-London Regional Cancer Centre
  • Toronto Sunnybrook Regional Cancer Centre
  • Princess Margaret Hospital
  • Maisonneuve-Rosemont Hospital
  • McGill University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 14, 2002
Last Updated
August 3, 2023
Sponsor
NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00030875
Brief Title
Bortezomib in Treating Patients With Mantle Cell Lymphoma
Official Title
A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Mantle Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 19, 2002 (Actual)
Primary Completion Date
July 21, 2005 (Actual)
Study Completion Date
December 21, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bortezomib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew R. Belch, MD
Organizational Affiliation
Cross Cancer Institute at University of Alberta
Official's Role
Study Chair
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Margaret and Charles Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Kingston Regional Cancer Centre
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Toronto Sunnybrook Regional Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16971665
Citation
Belch A, Kouroukis CT, Crump M, Sehn L, Gascoyne RD, Klasa R, Powers J, Wright J, Eisenhauer EA. 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):116-121. doi: 10.1093/annonc/mdl316. Epub 2006 Sep 13.
Results Reference
result
Citation
Belch A, Kouroukis CT, Crump M: Phase II trial of bortezomib in mantle cell lymphoma. [Abstract] Blood 104(11): A-608, 2004.
Results Reference
result
Citation
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.
Results Reference
result

Learn more about this trial

Bortezomib in Treating Patients With Mantle Cell Lymphoma

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