Combination Chemotherapy Followed By Antiviral Therapy and Interferon Alfa in Treating Patients With HTLV-1-Related Adult T-Cell Leukemia/Lymphoma
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|ClinicalTrials.gov Identifier: NCT00041327|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 3, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: filgrastim Biological: recombinant interferon alfa Drug: Etoposide Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: lamivudine Drug: prednisone Drug: vincristine sulfate Drug: zidovudine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
- Biological: filgrastim
5 ug/kg/dOther Name: Neupogen
- Biological: recombinant interferon alfa
9 mU subcutaneously per day for one year
- Drug: Etoposide
50 mg/m2/day continuous 96 hr infusion, days 1-4Other Name: VP-16
- Drug: cyclophosphamide
750 mg/m2 IV on day 5Other Name: cytoxan
- Drug: doxorubicin hydrochloride
10 mg/m2/day as a continuous 96-hour infusion days 1-4Other Name: adriamycin
- Drug: lamivudine
150 mg bidOther Name: epivir
- Drug: prednisone
60 mg/m2 given orally days 1-5Other Name: deltasone
- Drug: vincristine sulfate
0.4 mg/m2/day as a 96-hour continuous infusion days 1-4Other Name: Oncovin
- Drug: zidovudine
300 mg bidOther Name: AZT
- Efficacy [ Time Frame: 60 days ]
- Duration of response [ Time Frame: 3 years ]
- Effects on markers of virus replication and expression and immune function [ Time Frame: 5 years ]
- Toxicity [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|