RATIONALE: 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. PURPOSE: This phase II trial is studying how well gemcitabine works in treating patients with newly diagnosed, relapsed, or chemotherapy-resistant mantle cell lymphoma.
OBJECTIVES: Primary * Determine the efficacy of gemcitabine, in terms of objective response and tolerability, in patients with newly diagnosed, relapsed, or chemotherapy-resistant mantle cell lymphoma. Secondary * Determine the time to progression and time to treatment failure in patients treated with this drug. * Determine the response duration in patients treated with this drug. * Determine the adverse reactions in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years. PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 2 years.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Kantonspital Aarau
Aarau, Switzerland
Unnamed facility
Baden, Switzerland
Kantonsspital Baden
Baden, Switzerland
Objective response at end of study treatment
Adverse reactions at end of study treatment
Time to progression
Response duration
Time to treatment failure at end of study treatment
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Oncology Institute of Southern Switzerland
Bellinzona, Switzerland
Spital Buelach
Bülach, Switzerland
Kantonsspital - St. Gallen
Sankt Gallen, Switzerland
Spital Limmattal
Schlieren, Switzerland
Spital Uster
Uster, Switzerland
Kantonsspital Winterthur
Winterthur, Switzerland
Unnamed facility
Zurich, Switzerland
...and 6 more locations