Zidovudine, Interferon Alfa-2b, PEG-Interferon Alfa-2b in Patients With HTLV-I Associated Adult T-Cell Leukemia/Lymphoma
Condition: Lymphoma; Precancerous/Nonmalignant Condition
MeSH terms: Lymphoma; Leukemia; Leukemia, T-Cell; Leukemia-Lymphoma, Adult T-Cell; Precancerous Conditions
Intervention: PEG-interferon alfa-2b; Interferon alfa-2b; Valproic Acid; Zidovudine
Intervention description: Administered subcutaneously.; Administered intravenously.; Administered orally.; Administered intravenously during Induction Therapy; orally during Maintenance Therapy in all Phases (1, 2A and 2B).
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Zidovudine; Peginterferon alfa-2b; Valproic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent adult T-cell leukemia/lymphoma; 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; HTLV-1 infection

Summary:

      RATIONALE: Human T-cell lymphotropic virus type 1 (HTLV-1) can cause cancer. Zidovudine is an
      antiviral drug that acts against the human T-cell lymphotropic virus type 1. Giving
      zidovudine, interferon alfa-2b, and PEG-interferon alfa-2b together may stimulate the immune
      system and slow down or keep the cancer cell from growing.

      PURPOSE: This clinical trial is studying how well giving zidovudine together with interferon
      alfa-2b and PEG-interferon alfa-2b works in treating patients with human T-cell lymphotropic
      virus type 1-associated adult T-cell leukemia/lymphoma.
    

Eligibility criteria:

        Inclusion Criteria

          -  Any stage, histologically or cytological documented adult T-cell leukemia/lymphoma
             (ATLL), leukemic types only (smoldering, chronic or acute). See Appendix I for
             definitions of the clinical subtypes.

          -  Patients who have received prior treatment, including zidovudine and/or IFN, are
             eligible, provided that zidovudine/IFN therapy did not result in progressive disease.

          -  Documented HTLV-I infection: documentation may be serologic assay (ELISA, Western
             blot) and confirmed to be HTLV-I rather than HTLV-2 by differential Western blot
             (e.g., Genelabs Diagnostics HTLV Blot 2.4) or PCR.

          -  Measurable or evaluable disease.

          -  Age 18 or older.

          -  Karnofsky performance status ≥ 50%.

          -  Patients must have adequate end organ and bone marrow function as defined below:

               -  Absolute neutrophil count ≥ 1,000 cells/mm3 and platelets ≥ 50,000 cells/mm3
                  unless cytopenias are secondary to ATLL.

               -  Adequate hepatic function: (transaminase ≤ 7 times the upper limit of normal,
                  total bilirubin < 2.0), unless secondary to hepatic infiltration with lymphoma.
                  If the elevated bilirubin is felt to be secondary to Indinavir or Atazavinir
                  therapy (anti-HIV medications), patients will be allowed to enroll on protocol if
                  the total bilirubin is ≤ 3.5 mg/dl provided that the direct bilirubin is normal.

               -  Creatinine < 2.0 unless due to lymphomatous infiltration.

          -  Patients who are HIV+ are also eligible.

          -  Females with childbearing potential must have a negative serum pregnancy test within
             72 hours of entering into the study. Males and females must agree to use adequate
             birth control if conception is possible during the study. Women must avoid pregnancy
             and men avoid fathering children while in the study.

          -  Able to give consent.

          -  Patients already receiving erythropoietin or granulocyte-colony stimulating factor
             (G-CSF) are eligible.

        Exclusion Criteria

          -  Concurrent active malignancies, with the exception of in situ carcinoma of the cervix,
             non-metastatic, non-melanomatous skin cancer, or Kaposi's sarcoma not requiring
             systemic chemotherapy.

          -  Grade 3 or 4 cardiac failure and/or ejection fraction < 50%.

          -  Psychological, familial, sociological or geographical conditions that do not permit
             treatment and/or medical follow-up required to comply with the study protocol.

          -  Patients may not be receiving any other investigational agents.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Pregnant or breast-feeding women.

          -  Hypersensitivity to interferon alpha-2b, peginterferon alpha-2b, zidovudine or any
             component of the formulation

          -  Autoimmune or viral hepatitis or decompensated liver disease unless due to lymphoma.