Phase I Study of 90-Y-Humanized-BrE-3 Followed by Autologous Hematopoietic Progenitor Cell Support in Patients With Metastatic Breast Cancer
18 Years
N/A
Both
Breast Cancer
Trial Information
Phase I Study of 90-Y-Humanized-BrE-3 Followed by Autologous Hematopoietic Progenitor Cell Support in Patients With Metastatic Breast Cancer
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Roberto L. Ceriani, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Cancer Research Institute of Contra Costa
Authority:
United States: Federal Government
Study ID:
CRICC-BB-IND-7186
NCT ID:
NCT00007891
Start Date:
June 1997
Completion Date:
October 2004
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- male breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
| Cancer Research Institute of Contra Costa | San Francisco, California 94107 |
