Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well monoclonal antibody therapy, chemotherapy, and peripheral stem cell transplant work in treating patients with relapsed or refractory non-Hodgkin's lymphoma.
Procedure: peripheral blood stem cell transplantation
Radiation: tositumomab and iodine I 131 tositumomab
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||BEAM Plus Iodine-131 Anti-B1 Antibody and Autologous Hematopoietic Stem Cell Transplantation for Treatment of Recurrent Diffuse Large B-Cell Non-Hodgkin's Lymphoma|
- event free survival rate [ Time Frame: 100 days post transpat and at yearly intervals ] [ Designated as safety issue: No ]
- time to treatment failure [ Time Frame: time of registration to time of treatment discotinuation or withdrawal for progression ] [ Designated as safety issue: No ]
- over all survival [ Time Frame: when all treated patients have expired ] [ Designated as safety issue: No ]
|Study Start Date:||April 2000|
|Estimated Study Completion Date:||January 2015|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Iodine-131 Anti-B1 Antibody/BEAM/autologous hematopoietic stem cell transplantation (AHSCT)
300 mg/m2 IV on Day -6
Other Name: BCNUDrug: cytarabine
100 mg/m2 BID on Days -5 through -2Drug: etoposide
100 mg/m2 BID on Days -5 through -2Drug: melphalan
140 mg/m2 IV on Day -1Procedure: peripheral blood stem cell transplantation
Following the chemotherapy, on Day 0 of treatment, the previously stored hematopoietic stem cells will be administered to the patient intravenously through a central line to the patient.
Other Name: Autologous Hematopoietic Stem Cell TransplantationRadiation: tositumomab and iodine I 131 tositumomab
Patients will receive two administrations of Iodine-131 Anti-B1 Antibody; the "dosimetric dose" and the "therapeutic dose". The dosimetric dose will consist of an infusion of unlabeled Anti-B1 Antibody (450 mg) immediately followed by an infusion of Anti-B1 Antibody (35 mg) which has been trace labeled with 5 mCi of Iodine-131 Anti-B1 Antibody. Using whole body anterior and posterior gamma camera scans and serial imaging studies over approximately one week, the clearance of the whole body dosimetric dose will be used to calculate the subsequent therapeutic dose of Iodine-131 Anti-B1 Antibody which delivers a total body dose of 75 cGy to the subject
Other Name: Iodine-131 Anti-B1 Antibody
- Compare the response rates and time to treatment failure in patients with relapsed or refractory non-Hodgkin's lymphoma treated with iodine I 131 monoclonal antibody anti-B1, followed by high-dose carmustine, etoposide, cytarabine, and melphalan (BEAM), and autologous peripheral blood stem cell transplantation (APBSCT) vs historical control patients treated with high-dose BEAM or carmustine, etoposide, cytarabine, and cyclophosphamide and APBSCT.
- Determine the safety of this regimen in these patients.
OUTLINE: Autologous peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells or granulocyte macrophage colony-forming units. On day -19, patients receive unlabeled monoclonal antibody anti-B1 (MOAB anti-B1) IV followed by a dosimetric dose of iodine I 131 MOAB anti-B1 IV over 20 minutes. On day -12, patients receive unlabeled MOAB anti-B1 IV followed by a therapeutic dose of iodine I 131 MOAB anti-B1 IV over 20 minutes. Patients then receive high-dose chemotherapy comprising carmustine IV on day -6, etoposide IV and cytarabine IV twice daily on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous PBSC transplantation on day 0.
Patients are followed at days 30 and 100, at 6 months, and then annually thereafter.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006695
|United States, Nebraska|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-6805|
|Study Chair:||Julie M. Vose, MD||University of Nebraska|