Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
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. Combining chemotherapy with bone marrow or peripheral stem cell
      transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more
      tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by
      bone marrow or peripheral stem cell transplantation in treating patients with relapsed or
      refractory Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the curative potential of high-dose cyclophosphamide, etoposide, and cisplatin
           (CEP) followed by syngeneic or autologous bone marrow and/or autologous peripheral blood
           stem cell (PBSC) rescue in patients with relapsed or refractory stage I-IV Hodgkin's
           lymphoma.

        -  Determine the overall response rate and survival of patients treated with this regimen.

        -  Determine the toxicity of this regimen in these patients.

        -  Determine the differences in the rate of engraftment, response, and survival of patients
           treated with bone marrow vs PBSC transplantation.

        -  Determine the response rate and survival of patients treated with late consolidative
           radiotherapy after recovery from transplantation.

        -  Determine the toxicity of late 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 or 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 Hodgkin lymphoma; stage II adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; recurrent adult Hodgkin lymphoma