Lymphoma
Conditions
Keywords
recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult T-cell leukemia/lymphoma, anaplastic large cell lymphoma
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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)
Countries
Canada, United States