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| Tracking Information | |||||
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| First Received Date ICMJE | July 11, 2001 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | February 2001 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00020410 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Radiolabeled Monoclonal Antibody Followed by Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Metastatic Breast Cancer | ||||
| Official Title ICMJE | Phase I Study Of Yttrium 90-Labeled Monoclonal Antibody B3 With Autologous Stem Cell Support For Metastatic Breast Cancer | ||||
| Brief Summary | RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of monoclonal antibody therapy and kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody followed by peripheral stem cell transplantation in treating patients who have relapsed or metastatic breast cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a dose-escalation study of yttrium Y 90 monoclonal antibody B3 (Y90 MOAB B3). Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 4 days prior to peripheral blood stem cell (PBSC) collection and continuing until the target number of cells is reached. After PBSC collection, patients receive indium In 111 monoclonal antibody B3 IV over 30-60 minutes once within days -7 to -1 for tumor imaging and then Y90 MOAB B3 IV over 30-60 minutes on day 0. After at least day 7, patients undergo autologous PBSC reinfusion. Patients receive G-CSF SC daily beginning 7 days after PBSC reinfusion and continuing until blood counts recover. Cohorts of 3-6 patients receive escalating doses of Y90 MOAB B3 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 1 week, 1 month, and then every 2 months thereafter. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 24-36 months. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Sex:
Menopausal status:
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 | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00020410 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068405, NCI-00-C-0206, NCI-213 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | September 2003 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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