Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
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. Combining more than one drug may kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of
      liposomal doxorubicin, cyclophosphamide, vincristine, and prednisone in treating patients
      with AIDS-related lymphoma.
    

Detailed description: 
      OBJECTIVES: I. Determine the one year survival and complete response rate of patients treated
      with doxorubicin HCl liposome/cyclophosphamide/vincristine/prednisone (Doxil-CVP) for
      AIDS-related lymphoma. II. Evaluate the toxicity of a combination chemotherapy regimen,
      Doxil-CVP, in this patient population. III. Evaluate the progression free and overall
      survival after treatment with Doxil-CVP in this patient population. IV. Evaluate the effects
      of treatment with Doxil-CVP on plasma viral mRNA levels, CD4+ lymphocyte count, and the
      incidences and types of opportunistic infections in this patient population.

      OUTLINE: Patients are stratified according to disease characteristics. All patients receive a
      30 minute infusion of doxorubicin HCl liposome IV, cyclophosphamide IV, and vincristine IV on
      day 1. Patients also receive oral prednisone on days 1-5. Filgrastim (G-CSF) is administered
      subcutaneously starting on day 6 and continues until the absolute neutrophil count is at
      least 10,000/mm3. Treatment courses are repeated every 21 days. Patients with lymphomatous
      bone marrow involvement and/or category J lymphoma receive cytarabine and methotrexate
      intrathecally weekly for 4 weeks. Patients with lymphomatous meningitis receive whole brain
      irradiation and an alternating intrathecal chemotherapy regimen. A minimum of 4 and a maximum
      of 8 courses are administered. Patients are removed from the study for progressive disease,
      stable disease after 4 courses, a life threatening infection that would delay treatment for
      more than 6 weeks, or any delay, except due to neutropenia, in chemotherapy treatment for
      more than 6 weeks. Patients who achieve a complete response receive an additional 2 courses
      of therapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and
      annually thereafter.

      PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study.
    

Intervention name(s): filgrastim; cyclophosphamide; cytarabine; methotrexate; pegylated liposomal doxorubicin hydrochloride; prednisone; vincristine sulfate; radiation therapy
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Drug; Drug; Radiation
Intervention MeSH terms: Cytarabine; Prednisone; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Methotrexate; Vincristine
Primary purpose: Treatment
Keywords: AIDS-related peripheral/systemic lymphoma; AIDS-related diffuse large cell lymphoma; AIDS-related immunoblastic large cell lymphoma; AIDS-related small noncleaved cell lymphoma; AIDS-related diffuse mixed cell lymphoma; AIDS-related diffuse small cleaved cell lymphoma; AIDS-related lymphoblastic lymphoma; anaplastic large cell lymphoma