NCT00041327

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: AIDS Malignancy Consortium · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim	5 ug/kg/d
BIOLOGICAL	recombinant interferon alfa	9 mU subcutaneously per day for one year
DRUG	Etoposide	50 mg/m2/day continuous 96 hr infusion, days 1-4
DRUG	cyclophosphamide	750 mg/m2 IV on day 5
DRUG	doxorubicin hydrochloride	10 mg/m2/day as a continuous 96-hour infusion days 1-4
DRUG	lamivudine	150 mg bid
DRUG	prednisone	60 mg/m2 given orally days 1-5
DRUG	vincristine sulfate	0.4 mg/m2/day as a 96-hour continuous infusion days 1-4
DRUG	zidovudine	300 mg bid

Timeline

• Start date: 2002-10-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2003-01-27
• Last updated: 2016-02-03

Locations

3 sites across 1 country: United States