Combination Chemotherapy and Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Bone marrow and peripheral stem cell transplantation may allow
      doctors to give high doses of chemotherapy and kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with
      cyclophosphamide, etoposide and cisplatin followed by bone marrow and/or peripheral stem cell
      transplantation in patients with relapsed or refractory intermediate- or high-grade
      non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the curative potential of high-dose cyclophosphamide, etoposide, and cisplatin
           (CEP) with syngeneic or autologous bone marrow and/or autologous peripheral blood stem
           cell rescue in patients with relapsed or refractory, stage I-IV, intermediate- or
           high-grade non-Hodgkin's lymphoma.

        -  Determine the overall response rate and survival of patients treated with this regimen.

        -  Determine the toxic effects of this regimen in these patients.

        -  Determine the differences in the rates of engraftment, response, and survival of
           patients treated with bone marrow vs peripheral blood stem cell transplantation.

        -  Determine the response rate and survival of patients treated with consolidative
           radiotherapy after recovery from transplantation.

        -  Determine the toxic effects of consolidative radiotherapy after recovery from
           transplantation in these patients.

      OUTLINE: Syngeneic or autologous bone marrow and/or autologous peripheral blood stem cells
      (PBSC) are harvested. Syngeneic bone marrow transplantation is preferred for patients with a
      qualifying identical twin donor. Patients without a syngeneic donor who have a history of
      lymphomatous involvement of the bone marrow and are profoundly hypocellular undergo harvest
      of PBSC alone. Patients without a syngeneic donor who have no history of lymphomatous
      involvement of the bone marrow undergo harvest of autologous bone marrow or PBSC.

      Patients receive conditioning comprising cyclophosphamide IV over 1 hour on days -6 to -3 and
      etoposide IV over 1 hour every 12 hours and cisplatin IV continuously on days -6 to -4. Bone
      marrow and/or PBSC are infused on day 0. (Patients requiring more than 25 bags of stem cells
      receive bone marrow transplantation on day 0 and PBSC transplantation on day 1.)

      After recovery from transplantation, eligible patients receive consolidative radiotherapy to
      any site of prior bulk disease (greater than 5 cm) present at any time before transplantation
      and any site of disease present at the time of transplantation.

      Patients are followed at 3, 6, and 12 months and then annually thereafter.

      PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.
    

Intervention name(s): cisplatin; cyclophosphamide; etoposide; autologous bone marrow transplantation; bone marrow ablation with stem cell support; peripheral blood stem cell transplantation; syngeneic bone marrow transplantation; radiation therapy
Intervention type(s): Drug; Drug; Drug; Procedure; Procedure; Procedure; Procedure; Radiation
Intervention MeSH terms: Cyclophosphamide; Etoposide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage I adult diffuse small cleaved cell lymphoma; stage I adult diffuse mixed cell lymphoma; stage I adult diffuse large cell lymphoma; stage I adult immunoblastic large cell lymphoma; stage I adult lymphoblastic lymphoma; stage I adult Burkitt lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse large cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage III adult lymphoblastic lymphoma; stage III adult Burkitt lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV adult lymphoblastic lymphoma; stage IV adult Burkitt lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent adult Burkitt lymphoma; contiguous stage II adult diffuse small cleaved cell lymphoma; contiguous stage II adult diffuse mixed cell lymphoma; contiguous stage II adult immunoblastic large cell lymphoma; contiguous stage II adult diffuse large cell lymphoma; contiguous stage II adult Burkitt lymphoma; contiguous stage II adult lymphoblastic lymphoma; noncontiguous stage II adult diffuse small cleaved cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult lymphoblastic lymphoma