drugset / Trial / NCT00041327

Combination Chemotherapy Followed By Antiviral Therapy and Interferon Alfa in Treating Patients With HTLV-1-Related Adult T-Cell Leukemia/Lymphoma

NCT00041327

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2002-10
Primary completion
2006-12
Completion
2006-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 10 mg/m2 Intravenous
Subject Etoposide Small molecule 50 mg/m2 Intravenous
Subject Lamivudine Other / unclassified 150 mg Oral
Subject Prednisone Other / unclassified 60 mg/m2 Oral
Subject Vincristine Small molecule 0.4 mg/m2 Intravenous
Subject Zidovudine Small molecule 300 mg Oral
Subject interferon alfa-2b Protein / enzyme biologic 0.009 iu Subcutaneous
Background filgrastim Protein / enzyme biologic 5 ug/kg Subcutaneous

Indications