- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00007891
Radiolabeled Monoclonal Antibody Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Breast Cancer
Phase I Study of 90-Y-Humanized-BrE-3 Followed by Autologous Hematopoietic Progenitor Cell Support in Patients With Metastatic Breast Cancer
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 or bone marrow transplantation may be able to replace immune cells that were destroyed by monoclonal antibody therapy used to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have metastatic breast cancer.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Determine the maximum tolerated dose of yttrium Y 90 labeled, humanized monoclonal antibody BrE-3 when given in combination with indium In 111 labeled, humanized monoclonal antibody BrE-3 followed by autologous bone marrow or peripheral blood stem cell transplantation in patients with metastatic breast cancer.
- Determine hematopoietic engraftment in these patients treated with this regimen.
- Determine the ability of indium In 111 labeled, humanized monoclonal antibody BrE-3 to image metastatic disease in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the preliminary antitumor response in these patients treated with this regimen.
OUTLINE: This is a dose escalation study of yttrium Y 90 labeled, humanized monoclonal antibody BrE-3 (Y90 huMOAB BrE-3).
Patients receive Y90 huMOAB BrE-3 and indium In 111 labeled, humanized monoclonal antibody BrE-3 IV over 1-2 hours on day -14. Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0. Patients also receive filgrastim (G-CSF) IV beginning on day 0 and continuing until blood counts recover.
Cohorts of 3-6 patients receive escalating doses of Y90 huMOAB BrE-3 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 toxicities.
Patients are followed every 3-4 months for 1 year and then at least annually thereafter.
PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
San Francisco, California, United States, 94107
- Cancer Research Institute of Contra Costa
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Colorado
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Aurora, Colorado, United States, 80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic breast cancer
- BrE-3 positive
- Relapsed or refractory disease with tumor progression after effective therapy allowed
- Measurable or evaluable disease
Received at least one prior chemotherapy regimen for metastatic disease and have at least one of the following:
- Chemotherapy refractory liver metastases more than 2 cm
- Multiple non-resectable liver metastases
- Brain metastases
- Prior high-dose chemotherapy
- Relapse within prior radiotherapy field
Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Over 18
Sex:
- Male or female
Menopausal status:
- Not specified
Performance status:
- 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC greater than 3,000/mm3
- Absolute neutrophil count greater than 1,000/mm3
- Platelet count greater than 100,000/mm3
Hepatic:
- Bilirubin less than 2 times normal
- SGOT/SGPT less than 2 times normal
Renal:
- Creatinine clearance greater than 60 mL/min
Cardiovascular:
- LVEF greater than 45% by MUGA scan
Pulmonary:
- DLCO and FEV 1.0 greater than 60% predicted
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known hypersensitivity to E. coli derived proteins
- No other comorbid condition that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior high-dose chemotherapy with autologous peripheral blood stem cell transplantation
Chemotherapy:
- See Disease Characteristics
- See Biologic therapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- Not specified
Other:
- Recovered from prior therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: Roberto L. Ceriani, MD, PhD, Cancer Research Institute of Contra Costa
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRICC-BB-IND-7186
- CDR0000068340 (Registry Identifier: PDQ (Physician Data Query))
- UCHSC-97467
- NCI-V00-1637
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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