Bortezomib in Treating Patients With Mantle Cell Lymphoma

Lymphoma Clinical Trial

Official title:

A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Mantle Cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00030875
• Other study ID #: I150
• Secondary ID: CAN-NCIC-IND150C
• Status: Completed
• Phase: Phase 2
• Start date: November 19, 2002
• Est. completion date: December 21, 2009

Study information

• Verified date: April 2020
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 21, 2009
• Est. primary completion date: July 21, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell

Intervention

Drug:
• bortezomib

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario
Canada	Kingston Regional Cancer Centre	Kingston	Ontario
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec
Canada	McGill University	Montreal	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	British Columbia Cancer Agency	Vancouver	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
NCIC Clinical Trials Group

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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 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) — View Citation

Belch A, Kouroukis CT, Crump M: Phase II trial of bortezomib in mantle cell lymphoma. [Abstract] Blood 104(11): A-608, 2004.