Status:
COMPLETED
Bortezomib and Gemcitabine in Treating Patients With Relapsed Mantle Cell Lymphoma
Lead Sponsor:
NCIC Clinical Trials Group
Conditions:
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as gemcitabi...
Detailed Description
OBJECTIVES: * Determine the efficacy (response rate) of bortezomib and gemcitabine hydrochloride in patients with relapsed mantle cell lymphoma. * Determine the toxicity of this regimen in these pati...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed mantle cell lymphoma
- Relapsed disease
- Not refractory to prior therapy
- Must have received 1-3 prior systemic chemotherapy regimens AND has had no disease progression while receiving chemotherapy or within 1 month of last dose of most recent therapy
- Clinically and/or radiologically documented disease
- At least 1 site of disease must be bidimensionally measurable by CT scan or MRI with ≥ 1 lesion meeting 1 of the following criteria:
- Lymph nodes ≥ 1.5 cm x 1.5 cm by spiral CT scan
- Non-nodal lesion ≥ 1 cm x 1 cm by MRI, CT scan, or physical exam
- No nonmeasurable disease only
- No preexisting ascites or pleural effusion ≥ grade 2
- No known CNS involvement by lymphoma
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy ≥ 12 weeks
- Absolute granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 75,000/mm³
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- AST or ALT ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- LVEF ≥ 45% by echocardiogram or MUGA
- No history of allergic reactions attributed to compounds containing boron or mannitol
- No preexisting edema ≥ grade 2
- No preexisting neuropathy (sensory and/or pain) ≥ grade 2
- No preexisting shortness of breath ≥ grade 2
- No history of other malignancies, except adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years
- No other serious illness or medical condition that would preclude compliance with study requirements, including any of the following:
- Serious uncontrolled infection
- Uncontrolled or severe cardiovascular disease, including any of the following:
- Myocardial infarction within the past 6 months
- New York Heart Association class III-IV heart failure
- Uncontrolled angina
- Clinically significant pericardial disease
- Cardiac amyloidosis
- Significant neurological disorder
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 6 weeks since prior chemotherapy
- No prior radioactive monoclonal antibody therapy
- No prior bortezomib
- No prior investigational therapy (except for flavopiridol)
- No prior radiotherapy to \> 25% of functioning bone marrow
- At least 4 weeks since prior radiotherapy and recovered
- Low-dose, nonmyelosuppressive radiotherapy may be allowed
- At least 2 weeks since prior major surgery
- No other concurrent anticancer therapy
- No concurrent corticosteroids
- No other concurrent cytotoxic chemotherapy
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
January 16 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2011
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00377052
Start Date
January 16 2007
End Date
June 21 2011
Last Update
August 4 2023
Active Locations (11)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
2
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
3
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
4
QEII Health Sciences Center
Halifax, Nova Scotia, Canada, B3H 1V7