Lymphoma
Conditions
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
Brief 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.
Detailed description
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.
Interventions
DRUGgemcitabine hydrochloride
Sponsors
Swiss Cancer Institute
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response at end of study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions at end of study treatment | — |
| Time to progression | — |
| Response duration | — |
| Time to treatment failure at end of study treatment | — |
Countries
Switzerland
Outcome results
None listed