combination chemotherapy followed by antiviral therapy and interferon alfa in treating patients with htlv-1-related adult t-cell leukemia/lymphoma

Conditions: Lymphoma

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. antiviral therapy may kill viruses such as htlv-1 that can cause cancer. interferon alfa may interfere with the growth of cancer cells. combining chemotherapy with antiviral drugs and interferon alfa may be effective in treating adult t-cell leukemia/lymphoma. purpose: phase ii trial to determine the effectiveness of combination chemotherapy followed by antiviral therapy and interferon alfa in treating patients who have adult t-cell leukemia/lymphoma caused by htlv-1.

objectives: * determine the efficacy of etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (epoch) followed by lamivudine, zidovudine, and interferon alfa, in terms of response rate, in patients with htlv-1-associated adult t-cell leukemia/lymphoma. * determine the duration of response in patients treated with this regimen. * determine the toxicity of this regimen in these patients. * determine the effect of this regimen on markers of virus replication and expression and immune function in these patients. outline: this is a multicenter study. patients receive epoch chemotherapy comprising etoposide, vincristine, and doxorubicin iv continuously on days 1-5, cyclophosphamide iv over 30 minutes on day 5, and oral prednisone on days 1-5. patients also receive filgrastim (g-csf) subcutaneously (sc) daily beginning on day 7 and continuing until blood counts recover. treatment repeats every 21-28 days for at least 2 courses beyond best response or for up to 6 courses in the absence of unacceptable toxicity, disease progression, or stable disease. beginning 1 month after completion of epoch, patients receive oral lamivudine and zidovudine twice daily and interferon alfa sc daily continuously for 1 year. patients are followed monthly for 1 year, every 2 months for 1 year, and then every 6 months for 3 years. projected accrual: a total of 10-32 patients will be accrued for this study within 1-2 years.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed htlv-1-associated adult t-cell leukemia/lymphoma (atll) * previously treated atll allowed * cd3-positive * documented htlv-1 infection by serologic assay (elisa, western blot) * measurable or evaluable disease patient characteristics: age: * 18 and over performance status: * karnofsky 50-100% life expectancy: * not specified hematopoietic: * absolute neutrophil count greater than 1,000/mm\^3\* * platelet count greater than 75,000/mm\^3\* note: \*unless cytopenia is secondary to atll hepatic: * transaminase less than 7 times upper limit of normal * bilirubin less than 2.0 mg/dl (unless secondary to hepatic infiltration with lymphoma or isolated indirect hyperbilirubinemia associated with indinavir) renal: * creatinine less than 2.0 mg/dl (unless due to lymphoma) other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 6 months after study completion * no active opportunistic infection requiring acute therapy * no untreated thyroid disease * no autoimmune disease * no uncontrolled significant psychiatric disease * no other concurrent malignancy except carcinoma in situ of the cervix or non-metastatic nonmelanoma skin cancer prior concurrent therapy: biologic therapy: * at least 24 hours since prior hematologic growth factors chemotherapy: * not specified endocrine therapy: * not specified radiotherapy: * not specified surgery: * not specified other: * concurrent chronic therapy with potentially myelosuppressive agents allowed * other concurrent antiretroviral therapy for hiv, hepatitis b, or hepatitis c infection (or other indication) allowed at investigator's discretion for patients receiving therapy prior to study initiation

Keywords: stage i adult t-cell leukemia/lymphoma stage ii adult t-cell leukemia/lymphoma stage iii adult t-cell leukemia/lymphoma stage iv adult t-cell leukemia/lymphoma