liposomal vincristine in treating patients with refractory or relapsed non-hodgkin's lymphoma

Conditions: Lymphoma

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of liposomal vincristine in treating patients who have refractory or relapsed non-hodgkin's lymphoma.

objectives: * determine the complete and partial tumor responses in patients with aggressive non-hodgkin's lymphoma that is refractory to or relapsed after second-line combination chemotherapy treated with vincristine sulfate liposomes injection. * determine the toxicity of this treatment regimen in these patients. * determine the duration of response, time to progression, and survival in patients treated with this regimen. outline: this is a multicenter study. patients receive vincristine sulfate liposomes iv over 1 hour. treatment repeats every 2 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 8 weeks until disease progression. projected accrual: a total of 100 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: * histologically confirmed aggressive non-hodgkin's lymphoma including: * peripheral t-cell lymphoma not otherwise specified * anaplastic large null-/t-cell lymphoma * diffuse large b-cell lymphoma including: * primary mediastinal large b-cell lymphoma with sclerosis * intravascular large b-cell lymphoma * immunoblastic b-cell lymphoma * t-cell-rich b-cell lymphoma * anaplastic large b-cell lymphoma * at least one bidimensionally measurable lesion with clearly defined margins at least 2 cm in the largest dimension by physical examination or ct scan * no prior or active cns lymphoma or aids-related lymphoma * must have received 2 or more prior chemotherapy courses from time of diagnosis of aggressive lymphoma or from time of biopsy-proven transformation from indolent to aggressive * prior first and second-line therapy must have been combination chemotherapy * prior first-line chemotherapy regimen must have contained anthracycline * must have had at least a minor response to first-line therapy patient characteristics: age: * 18 and over performance status: * ecog 0-3 life expectancy: * not specified hematopoietic: * granulocyte count at least 500/mm\^3 (unless due to lymphoma bone marrow involvement) * platelet count at least 50,000/mm\^3 (unless due to lymphoma bone marrow involvement) hepatic: * bilirubin no greater than 2 times upper limit of normal (uln) * alt no greater than 4 times uln * alkaline phosphatase no greater than 4 times uln renal: * not specified neurologic: * no prior neurological disorders unrelated to chemotherapy (including familial neurological diseases or acquired demyelinating disorders) * no neuromuscular impairment (neuromotor, neurosensory, or neurocerebellar) * no prior grade 3 or 4 sensory or motor neuropathy related to chemotherapy other: * no uncontrolled severe medical illness or infection * hiv negative * no other malignancies within the past 5 years except curatively resected basal cell skin cancer or carcinoma in situ of the cervix * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * see radiotherapy * no prior allogeneic bone marrow or peripheral blood stem cell transplantation * at least 4 weeks since prior immunotherapy * no concurrent biological agents chemotherapy: * see disease characteristics * at least 4 weeks since prior chemotherapy endocrine therapy: * at least 4 weeks since prior corticosteroids at a dose greater than 10 mg/day of prednisone or equivalent radiotherapy: * prior involved-field radiotherapy allowed if irradiated area is not the only source of measurable disease * prior total body radiotherapy with high-dose therapy and autologous stem cell transplantation allowed * at least 4 weeks since prior radiotherapy * no concurrent radiotherapy to any disease site surgery: * at least 4 weeks since prior major surgery except for diagnosis of lymphoma * no concurrent surgical removal of any indicator lesion other: * at least 4 weeks since prior alternative or investigational anticancer treatment * no other concurrent systemic anticancer therapy * no other concurrent investigational drug * no concurrent phenytoin * no concurrent hepatic drug metabolism inhibitors or inducers (cytochrome p450 isoenzymes in the cyp 3a subfamily)

Keywords: recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult t-cell leukemia/lymphoma anaplastic large cell lymphoma