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| Sponsor: | University of Nebraska |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| 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: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation Radiation: tositumomab and iodine I 131 tositumomab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| 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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2000 |
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
| Study ID Numbers: | CDR0000068308, UNMC-051-00, COULTER-IND-3323 |
| Study First Received: | December 6, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006695 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma |
|
Antimetabolites Anti-Infective Agents Melphalan Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Iodine-131 anti-B1 antibody Lymphoma, B-Cell Antibodies, Monoclonal Therapeutic Uses Iodine Micronutrients Lymphoma |
Etoposide Alkylating Agents Cytarabine Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Growth Substances Carmustine Trace Elements Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Anti-Infective Agents, Local Lymphatic Diseases Neoplasms |