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Phase I Study of 90-Y-Humanized-BrE-3 Followed by Autologous Hematopoietic Progenitor Cell Support in Patients With Metastatic Breast Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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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 CenterDenver, Colorado  80010
Cancer Research Institute of Contra CostaSan Francisco, California  94107