Combination Chemotherapy Followed By Antiviral Therapy and Interferon Alfa in Treating Patients With HTLV-1-Related Adult T-Cell Leukemia/Lymphoma
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.
Biological: recombinant interferon alfa
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial Of Induction Therapy With EPOCH Chemotherapy And Maintenance Therapy With Combivir/Interferon ALPHA-2a For HTLV-1 Associated T-Cell Non-Hodgkin's Lymphoma|
- Efficacy [ Time Frame: 60 days ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Effects on markers of virus replication and expression and immune function [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2002|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041327
|United States, California|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90089-9181|
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center|
|Miami, Florida, United States, 33136|
|United States, Missouri|
|Siteman Cancer Center at Barnes-Jewish Hospital|
|Saint Louis, Missouri, United States, 63110|
|Study Chair:||Lee Ratner, MD, PhD||Washington University Siteman Cancer Center|