Combination Chemotherapy With or Without Total-Body Irradiation Followed By Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Giving chemotherapy and radiation therapy to the entire body before an autologous
      peripheral stem cell transplant stops the growth of cancer cells by stopping them from
      dividing or killing them. The patient's stem cells are then returned to the patient to
      replace the blood-forming cells that were destroyed by the chemotherapy and radiation
      therapy.

      PURPOSE: This phase II trial is studying the side effects of giving combination chemotherapy
      together with or without total-body irradiation followed by a stem cell transplant and to see
      how well it works in treating patients with non-Hodgkin lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  To evaluate the outcome of patients with poor-risk, age-adjusted International
           Prognostic Index high- and high-intermediate-risk, intermediate- and high-grade
           non-Hodgkin lymphoma undergoing high-dose therapy comprising etoposide and
           cyclophosphamide, either carmustine or total-body irradiation, and autologous stem cell
           transplantation (ASCT) given as a consolidation therapy.

        -  To evaluate the role of high-dose therapy and ASCT during first partial or complete
           remission (1PR/CR) in patients with poor-risk primary mediastinal large cell lymphoma.

        -  To evaluate the role of high-dose therapy and ASCT during first 1PR/CR in patients with
           advanced-stage mantle cell lymphoma.

        -  To evaluate the short-term and long-term toxicities of high-dose therapy and ASCT when
           performed during 1PR/CR in patients with poor-risk aggressive lymphomas.

      OUTLINE: Patients are stratified according to disease (diffuse mixed, diffuse large cell, and
      immunoblastic lymphoma vs primary mediastinal large cell lymphoma vs small noncleaved cell
      lymphoma vs stage IV mantle cell lymphoma).

      Patients' peripheral blood stem cells (PBSC) are collected after mobilization. A minimum of
      2.0 x 10^6 CD34+ cells/kg must be collected. Patients experiencing disease progression during
      stem cell collection will be removed from study. Patients are assigned to undergo 1 of 2
      therapeutic regimens.

        -  Regimen 1: Patients undergo total-body irradiation (TBI) on days -8 to -5 and receive
           etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2.
           Patients undergo autologous PBSC transplantation on day 0.

        -  Regimen 2 (for patients who have received any prior thoracic irradiation or patients who
           underwent previous irradiation that precludes the use of TBI): Patients receive
           carmustine IV over 2 hours on days -7 to -5. Patients then receive etoposide and
           cyclophosphamide and undergo autologous PBSC transplantation as in regimen 1.

      Patients with residual bulky disease greater than 5 cm may undergo involved-field
      radiotherapy before or after transplantation.

      Patients are followed at days 7, 14, 21, 100 and 180 after PBSC transplantation, every 6
      months for 3 years, and then annually thereafter.
    

Intervention name(s): carmustine; cyclophosphamide; etoposide; autologous hematopoietic stem cell transplantation; peripheral blood stem cell transplantation; total-body irradiation; G-CSF
Intervention type(s): Drug; Drug; Drug; Procedure; Procedure; Radiation; Drug
Intervention description(s): Unique to the Carmustine in Conditioning arm; Used in Both Arms; Used in Both Arms; Both arms are given autologous stem cell transplantation; Both arms are given peripheral blood stem cell transplantation (Peripheral blood stem cells are the material, autologous transplant is the modality).; Unique to the Radiation in Conditioning Arm; G-CSF is given in both treatment arms, both to mobilize stem cells before apheresis, and to promote recovery of granulocytes after stem-cell re-infusion.
Other intervention name(s): BCNU; Cytoxan, CTX; VP-16; Granulocyte-colony stimulating factor
Intervention MeSH terms: Cyclophosphamide; Carmustine; Etoposide; Lenograstim
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III adult diffuse mixed cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV mantle cell lymphoma; stage III mantle cell lymphoma; stage III adult diffuse large cell lymphoma; stage IV adult diffuse large cell lymphoma; stage III adult Burkitt lymphoma; stage IV adult Burkitt lymphoma