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| Descriptive Information Fields | |||||
| Brief Title † | Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma | ||||
| 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Open Label | ||||
| Primary Outcome Measure † | Maximum tolerated dose [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | Clinical activity as assessed by tumor measurements using serial post-injection MRI scans, daily steroid use, and Karnofsky performance status evaluation [ Designated as safety issue: No ] Time to tumor progression assessed by tumor measurements using MRI [ Designated as safety issue: No ] Response [ Designated as safety issue: No ] Overall survival [ Designated as safety issue: No ] |
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| Condition † | Lymphoma | ||||
| Intervention † | Drug: carmustine Drug: cytarabine Drug: etoposide Drug: melphalan Drug: tositumomab and iodine I 131 tositumomab Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 50 | ||||
| Start Date † | April 2000 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 19 Years to 70 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00006695 | ||||
| Organization ID | CDR0000068308 | ||||
| Secondary IDs †† | UNMC-051-00, COULTER-IND-3323 | ||||
| Study Sponsor † | University of Nebraska | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | September 2006 | ||||
| First Received Date † | December 6, 2000 | ||||
| Last Updated Date | July 23, 2008 | ||||