Interleukin-2 or Observation Following Radiation Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
Condition: Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma
MeSH terms: Burkitt Lymphoma; Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized phase III trial to compare the effectiveness of interleukin-2 with that of
      observation following radiation therapy, combination chemotherapy, and peripheral stem cell
      transplantation in treating patients who have refractory or relapsed non-Hodgkin's lymphoma.
      Interleukin-2 may stimulate a person's white blood cells to kill non-Hodgkin's lymphoma
      cells. Giving interleukin-2 after radiation therapy, chemotherapy, and peripheral stem cell
      transplantation may kill more cancer cells
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To compare the survival and disease-free survival of patients with non-Hodgkin's lymphoma
      treated with post-transplant therapy with interleukin-2 (IL-2) or no further treatment.
      Transplant therapy is total body irradiation (TBI), high-dose etoposide, cyclophosphamide and
      peripheral blood stem cell transplant (PBSCT).

      II. To assess the frequency and severity of toxicity associated with post-transplant IL-2
      therapy.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      disease grade (low vs intermediate vs high), chemosensitive disease (yes vs no), partial or
      complete response after initial induction chemotherapy (yes vs no), and performance status
      (0-1 vs 2).

      Part I: Autologous peripheral blood stem cells (PBSC) are harvested before study entry.
      Patients undergo total body irradiation twice a day on days -8 to -5, high-dose etoposide IV
      over 4 hours on day -4, and cyclophosphamide IV over 1 hour on day -2. PBSC are reinfused on
      day 0 and then filgrastim (G-CSF) may be administered subcutaneously or IV on days 0-21.

      Part II: Within 28-80 days after PBSC transplantation and after recovery from any toxic
      effects, patients with no active recurrent or progressive disease are randomized to 1 of 2
      treatment arms.

      Arm I: Patients receive interleukin-2 IV continuously on days 1-4 and 9-18.

      Arm II: Patients undergo observation only.

      Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: Approximately 275 patients will be accrued for this study within 3.5-5.9
      years.
    

Intervention name(s): aldesleukin; filgrastim; cyclophosphamide; etoposide; radiation therapy; peripheral blood stem cell transplantation; bone marrow ablation with stem cell support
Intervention type(s): Biological; Biological; Drug; Drug; Radiation; Procedure; Procedure
Intervention description(s): Given IV; Given SC or IV; Given IV; Given IV; Undergo radiation therapy; Undergo autologous peripheral blood stem cell transplant; Undergo bone marrow ablation with stem cell support
Other intervention name(s): IL-2; Proleukin; recombinant human interleukin-2; recombinant interleukin-2; G-CSF; Neupogen; CPM; CTX; Cytoxan; Endoxan; Endoxana; EPEG; VP-16; VP-16-213; irradiation; radiotherapy; therapy, radiation; PBPC transplantation; PBSC transplantation; peripheral blood progenitor cell transplantation; transplantation, peripheral blood stem cell
Intervention MeSH terms: Aldesleukin; Cyclophosphamide; Etoposide; Etoposide phosphate; Interleukin-2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment