Radiolabeled Monoclonal Antibody Followed by Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Determine the maximum tolerated dose of yttrium Y 90 monoclonal antibody B3 followed by autologous peripheral blood stem cell transplantation in patients with relapsed or metastatic breast cancer. Determine the toxicity of this treatment regimen in these patients. Determine the clinical response in patients treated with this regimen. 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.

Official Title
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Phase I Study Of Yttrium 90-labeled Monoclonal Antibody B3 With Autologous Stem Cell Support For Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: filgrastim
* Procedure: peripheral blood stem cell transplantation
* Radiation: yttrium Y 90 monoclonal antibody B3


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IV breast cancer At least 1 site of relapse or metastatic disease Progressive disease after at least 1 prior chemotherapy regimen for metastatic disease One regimen must contain an anthracycline and a taxane as adjuvant therapy or for metastatic disease Prior adjuvant chemotherapy allowed Measurable or evaluable disease Tumor tissue must express B3 antigen on the surface of more than 30% of tumor cells No CNS metastasis Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Male or female Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count greater than 2,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin normal SGOT and SGPT no greater than 2 times upper limit of normal PT normal Hepatitis B surface antigen negative Hepatitis C negative Renal: Creatinine no greater than 1.4 mg/dL Cardiovascular: Ejection fraction at least 45% by MUGA or echocardiogram Pulmonary: FEV_1 greater than 60% of predicted FVC at least 55% of predicted DLCO at least 55% of predicted Other: No known seizure disorders No history of autoimmune disease No other active malignancy except previously treated basal cell skin cancer No other concurrent medical or psychiatric condition that would preclude study participation HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy No prior mouse antibody Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered No prior high-dose chemotherapy with bone marrow or stem cell transplantation Endocrine therapy: At least 4 weeks since prior hormonal therapy No concurrent chronic steroids Radiotherapy: At least 4 weeks since prior local radiotherapy to one site and recovered No prior radiotherapy to the pelvis and/or spine Surgery: Not specified Other: No concurrent anticoagulants

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|
|Procedure: peripheral blood stem cell transplantation|nan|
|Radiation: yttrium Y 90 monoclonal antibody B3|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer, male breast cancer