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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00007891
First Posted: January 27, 2003
Last Update Posted: May 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention Phase
Breast Cancer Biological: filgrastim Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: indium In 111 monoclonal antibody BrE-3 Radiation: yttrium Y 90 monoclonal antibody BrE-3 Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study of 90-Y-Humanized-BrE-3 Followed by Autologous Hematopoietic Progenitor Cell Support in Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 1997
Study Completion Date: October 2004
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007891


Locations
United States, California
Cancer Research Institute of Contra Costa
San Francisco, California, United States, 94107
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
Sponsors and Collaborators
Cancer Research Institute of Contra Costa
Investigators
Study Chair: Roberto L. Ceriani, MD, PhD Cancer Research Institute of Contra Costa
  More Information

ClinicalTrials.gov Identifier: NCT00007891     History of Changes
Other Study ID Numbers: CRICC-BB-IND-7186
CDR0000068340 ( Registry Identifier: PDQ (Physician Data Query) )
UCHSC-97467
NCI-V00-1637
First Submitted: January 6, 2001
First Posted: January 27, 2003
Last Update Posted: May 15, 2013
Last Verified: September 2004

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs