Lymphoma Clinical Trial
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
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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