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| Sponsor: | University of Nebraska |
|---|---|
| Information provided by: | University of Nebraska |
| ClinicalTrials.gov Identifier: | NCT00006695 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: carmustine Drug: cytarabine Drug: etoposide Drug: melphalan Procedure: peripheral blood stem cell transplantation Radiation: tositumomab and iodine I 131 tositumomab |
Phase II |
| Study Type: | Interventional |
| 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 |
| Enrollment: | 50 |
| Study Start Date: | April 2000 |
| Estimated Study Completion Date: | January 2015 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Iodine-131 Anti-B1 Antibody/BEAM/autologous hematopoietic stem cell transplantation (AHSCT)
|
Drug: carmustine
300 mg/m2 IV on Day -6
Other Name: BCNU
Drug: cytarabine
100 mg/m2 BID on Days -5 through -2
Drug: etoposide
100 mg/m2 BID on Days -5 through -2
Drug: melphalan
140 mg/m2 IV on Day -1
Procedure: 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 Transplantation
Radiation: 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
|
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 19 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of non-Hodgkin's lymphoma (NHL) of one of the following types:
Adequate peripheral blood stem cells
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Cardiac ejection fraction at least 40% for any of the following criteria:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| 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 |
More Information
| Responsible Party: | Julie M. Vose, M.D., University of Nebraska Medical Center |
| ClinicalTrials.gov Identifier: | NCT00006695 History of Changes |
| Other Study ID Numbers: | 051-00, UNMC-051-00, COULTER-IND-3323 |
| Study First Received: | December 6, 2000 |
| Last Updated: | November 1, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma |
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Antibodies Immunoglobulins Antibodies, Monoclonal Cytarabine Melphalan Carmustine |
Iodine-131 anti-B1 antibody Etoposide Cadexomer iodine Iodine Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents |