Bortezomib in Treating Patients With Mantle Cell Lymphoma
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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 |
| Study Start Date: | July 2002 |
| Study Completion Date: | December 2009 |
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 |
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| 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 | |
| Study Chair: | Andrew R. Belch, MD | Cross Cancer Institute at University of Alberta |
More Information
Additional Information:
Publications:
| 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 Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013