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Home > "B" Clinical Trials Conditions > Bortezomib in Treating Patients With Mantle Cell Lymphoma  Bortezomib in Treating Patients With Mantle Cell Lymphoma
Bortezomib in Treating Patients With Mantle Cell Lymphoma
For Condition: recurrent mantle cell lymphoma,noncontiguous stage 2 mantle cell lymphoma,contiguous stage 2 mantle cell lymphoma,stage 1 mantle cell lymphoma,stage 4 mantle cell lymphoma,stage 3 mantle cell lymphoma
Status: Recruiting
Sponsor(s): National Cancer Institute of Canada ,
Synopsis: 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 relapsedmantle cell lymphoma.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AndrewBelch, Study Chair, Cross Cancer Institute
Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London, Ontario, N6A 4L6
Canada
Recruiting Kang Howson-Jan 519-685-5194
Margaret and Charles Juravinski Cancer Centre *Recruiting*
Hamilton, Ontario, L8V 5C2
Canada
Recruiting Tom Kouroukis 905-387-9711 ext. 62484
Kingston Regional Cancer Centre *Recruiting*
Kingston, Ontario, K7L 5P9
Canada
Recruiting John Matthews 613-533-6329
McGill University *Recruiting*
Montreal, Quebec, H2W 1S6
Canada
Recruiting Chaim Shustik 514-398-1444
British Columbia Cancer Agency *Recruiting*
Vancouver, British Columbia, V5Z 4E6
Canada
Recruiting Laurie Sehn 604-877-6000 ext. 2746
Cross Cancer Institute *Recruiting*
Edmonton, Alberta, T6G 1Z2
Canada
Recruiting Andrew Belch 780-432-8757
Maisonneuve-Rosemont Hospital *Recruiting*
Montreal, Quebec, H1T 2M4
Canada
Recruiting Jeannine Kassis 514-252-3404
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Michael Crump 416-946-4567
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Kevin Imrie 416-480-4757
CancerCare Manitoba *Recruiting*
Winnipeg, Manitoba, R3E 0V9
Canada
Recruiting Morel Rubinger 204-787-2113
Additional Information:
Study ID Numbers: CDR0000069207; CAN-NCIC-150
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030875
Other Stage 1 Mantle Cell Lymphoma Studies:
1. Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
2. Combination Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma
3. Rituximab and Cladribine in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
4. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma
5. Chemotherapy Plus Rituximab in Treating Patients With Mantle Cell Lymphoma
Related Studies:
Other stage 1 mantle cell lymphoma Clinical Trials
Other Ontario Clinical Trials
Other Toronto Clinical Trials
Bortezomib in Treating Patients With Mantle Cell Lymphoma
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