Radiolabeled Monoclonal Antibody Therapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Breast Cancer
Launched by CANCER RESEARCH INSTITUTE OF CONTRA COSTA · Jan 26, 2003
Trial Information
Current as of May 29, 2025
Completed
Keywords
ClinConnect Summary
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 th...
Gender
ALL
Eligibility 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
About Cancer Research Institute Of Contra Costa
The Cancer Research Institute of Contra Costa is a leading clinical research organization dedicated to advancing cancer treatment and prevention through innovative research methodologies. With a focus on conducting rigorous clinical trials, the institute collaborates with healthcare professionals and academic institutions to evaluate novel therapies and improve patient outcomes. Committed to fostering a patient-centered approach, the institute prioritizes safety, efficacy, and ethical standards in all its research initiatives, aiming to contribute significantly to the global fight against cancer.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Aurora, Colorado, United States
San Francisco, California, United States
Patients applied
Trial Officials
Roberto L. Ceriani, MD, PhD
Study Chair
Cancer Research Institute of Contra Costa
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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