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 gemcitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may help gemcitabine work better by making cancer cells more sensitive to the drug. PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine works in treating patients with relapsed mantle cell lymphoma.
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 patients. * Determine the time to progression and duration of response in patients treated with this regimen. OUTLINE: This is a nonrandomized, multicenter study. Patients receive bortezomib IV on days 1, 4, 8, and 11 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter until relapse/progression.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
1.0 mg/m2 IV; injection bolus (3-5 sec) Twice weekly x 2 weeks every three weeks
1000 mg/m2 IV; injection 30 minute infusion Once weekly x 2 weeks every three weeks
Cross Cancer Institute
Edmonton, Alberta, Canada
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Objective tumor response (overall response rate with 95% confidence interval)
Time frame: each cycle
Time to progression at median time
Time frame: each cycle and every 3 months after treatment
Duration of response (median and range)
Time frame: each cycle and every 3 months after treatment
Rate of stable disease and progressive disease
Time frame: each cycle and every 3 months after treatment
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QEII Health Sciences Center
Halifax, Nova Scotia, Canada
QEII, CCR, Hematology Research
Halifax, Nova Scotia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada
London Regional Cancer Program
London, Ontario, Canada
Odette Cancer Centre
Toronto, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada
McGill University - Dept. Oncology
Montreal, Quebec, Canada
...and 1 more locations