Combination Chemotherapy Followed By Antiviral Therapy and Interferon Alfa in Treating Patients With HTLV-1-Related Adult T-Cell Leukemia/Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Leukemia, T-Cell; Leukemia-Lymphoma, Adult T-Cell
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): filgrastim; recombinant interferon alfa; Etoposide; cyclophosphamide; doxorubicin hydrochloride; lamivudine; prednisone; vincristine sulfate; zidovudine
Intervention type(s): Biological; Biological; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 ug/kg/d; 9 mU subcutaneously per day for one year; 50 mg/m2/day continuous 96 hr infusion, days 1-4; 750 mg/m2 IV on day 5; 10 mg/m2/day as a continuous 96-hour infusion days 1-4; 150 mg bid; 60 mg/m2 given orally days 1-5; 0.4 mg/m2/day as a 96-hour continuous infusion days 1-4; 300 mg bid
Other intervention name(s): Neupogen; VP-16; cytoxan; adriamycin; epivir; deltasone; Oncovin; AZT
Intervention MeSH terms: Interferons; Interferon-alpha; Lamivudine; Zidovudine; Prednisone; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Etoposide; Vincristine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I adult T-cell leukemia/lymphoma; stage II adult T-cell leukemia/lymphoma; stage III adult T-cell leukemia/lymphoma; stage IV adult T-cell leukemia/lymphoma