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

May 14, 2013 updated by: Cancer Research Institute of Contra Costa

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94107
        • Cancer Research Institute of Contra Costa
    • Colorado
      • Aurora, Colorado, United States, 80010
        • University of Colorado Cancer Center at University of Colorado Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Research Institute of Contra Costa

Investigators

  • Study Chair: Roberto L. Ceriani, MD, PhD, Cancer Research Institute of Contra Costa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1997

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

January 6, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

September 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRICC-BB-IND-7186
  • CDR0000068340 (Registry Identifier: PDQ (Physician Data Query))
  • UCHSC-97467
  • NCI-V00-1637

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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