gemcitabine in treating patients with newly diagnosed, relapsed, or chemotherapy-resistant mantle cell lymphoma

Conditions: Lymphoma

Summary: 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.

Eligibility criteria:
disease characteristics: * histologically confirmed mantle cell lymphoma meeting 1 of the following criteria: * newly diagnosed * chemotherapy resistant * relapsed disease after no more than 2 prior lines of chemotherapy * measurable disease * at least 1 unidimensionally measurable lesion ≥ 11 mm by ct scan * no prior or current cns lymphoma or lymphomatous meningosis patient characteristics: age * 18 and over performance status * who 0-1 life expectancy * not specified hematopoietic * neutrophil count ≥ 1,500/mm\^3 (1,000/mm\^3 in case of bone marrow infiltration) * platelet count ≥ 100,000/mm\^3 (75,000/mm\^3 in case of bone marrow infiltration) hepatic * bilirubin ≤ 2 times upper limit of normal (uln) * alkaline phosphatase ≤ 2 times uln * ast and alt ≤ 2 times uln * no active hepatitis renal * creatinine clearance ≥ 50 ml/min cardiovascular * no congestive heart failure * no new york heart association class iii or iv heart disease * no unstable angina pectoris * no significant cardiac arrhythmia or arrhythmia requiring chronic treatment * no myocardial infarction within the past 3 months immunologic * no active autoimmune disease * no ongoing infection (e.g., hiv) other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 12 months after study participation * no other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix * no uncontrolled diabetes mellitus * no gastric ulcers * no other uncontrolled medical condition that would preclude study participation prior concurrent therapy: biologic therapy * no concurrent thalidomide chemotherapy * see disease characteristics endocrine therapy * not specified radiotherapy * prior radiotherapy allowed provided indicator lesions were not in the irradiated field * no concurrent radiotherapy to the lungs or mediastinum surgery * not specified other * more than 30 days since prior systemic anticancer treatment * more than 30 days since prior clinical trial participation * no other concurrent anticancer drugs * no other concurrent experimental drugs

Keywords: recurrent mantle cell lymphoma 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