NCT00162929

Brief Summary

The purpose of this study is to determine the maximum tolerated dose and/or maximum attainable dose of a vaccine consisting of human autologous dendritic cells transduced by an adenovector expressing rat Her-2/neu (AdHer-2/neu) in patients with metastatic breast cancer.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

June 4, 2012

Status Verified

May 1, 2012

Enrollment Period

4.5 years

First QC Date

September 10, 2005

Last Update Submit

May 31, 2012

Conditions

Metastatic Breast Cancer

Keywords

metastatic breast cancerlocally recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

  • toxicity

    weeks 4, 6, 7, 10, 14, 18, 22, 26

Secondary Outcomes (1)

  • tumour response

    Weeks 6, 18

Interventions

AdHer-2/neu transduced dendritic cellsBIOLOGICAL

Group 1 1 ×10'7 expanded cells (2.5 ×106 DCs per injection site) Group 2 5 ×10'7 expanded cells (1.25 ×107 DCs per injection site) Group 3 1 ×10'8 expanded cells (2.5 ×107 DCs per injection site)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Metastatic or locally recurrent breast cancer
  • years of age or older
  • Her-2/neu positive (3+ by immunohistochemistry or fluorescence in-situ hybridization \[FISH\] +)
  • One of the following:
  • currently receiving hormonal therapy or are candidates for such, or
  • being considered for trastuzumab, or
  • cancer has progressed on trastuzumab.

You may not qualify if:

  • Pregnant or lactating women.
  • Prior or concurrent malignancies except for treated basal cell or squamous cell carcinoma of the skin or in situ cancer of the cervix or any other cancer treated and presumed cured for more than five years prior to study entry.
  • Currently receiving chemotherapy, immunotherapy, adenoviral gene therapy or biological cancer therapy. \[Note: concurrent hormonal therapy (tamoxifen, aromatase inhibitors, or megace) is permitted.\]
  • Treatment with trastuzumab within 4 weeks prior to first dose of vaccine therapy.
  • Hemoglobin \< 80 g/L or granulocytes \< 1.5 × 10\^9/L or lymphocytes \< 1.0 × 10\^9/L or platelets \< 100 × 10\^9/L.
  • Baseline liver enzymes (AST or ALT) greater than 3 times the upper limit of normal or greater than 5 times the upper limit of normal if liver metastases are present and/or bilirubin is greater than 50 mmol.
  • CD4 cells \< 0.5 ×10\^9/L
  • Patients with documented brain metastases.
  • Patients with any acute illness that would interfere with the collection of CD34+ cells or administration of vaccination cellular therapy (i.e. unstable angina, renal or liver failure, or severe chronic obstructive airway disease).
  • Any patients requiring concurrent immunosuppressive therapy (e.g. corticosteroids).
  • Eastern Cooperative Oncology Group (ECOG) performance status of \> 2.
  • Patients with a life expectancy of less than 6 months.
  • Geographic inaccessibility which would preclude follow-up. Patients registered on the trial must be treated and followed at the Juravinski Cancer Center and the Henderson site of the Hamilton Health Sciences.
  • Failure to give written informed consent.
  • Baseline left ventricular ejection fraction (LVEF) \< 55% by echocardiography or multigated acquisition (MUGA) scan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sukhbinder Dhesy-Thind, M.D.

    Ontario Clinical Oncology Group; Juravinski Cancer Centre - Hamilton Health Sciences; McMaster University

    STUDY CHAIR

  • Ronan Foley, M.D.

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Richard Tozer, M.D.

    Juravinski Cancer Centre - Hamilton Health Sciences

    PRINCIPAL INVESTIGATOR

  • Peter Ellis, M.D.

    Juravinski Cancer Centre - Hamilton Health Sciences

    PRINCIPAL INVESTIGATOR

  • Jack Gauldie, M.D.

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Mark Levine, M.D.

    Ontario Clinical Oncology Group (OCOG)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 13, 2005

Study Start

January 1, 2005

Primary Completion

July 1, 2009

Study Completion

May 1, 2012

Last Updated

June 4, 2012

Record last verified: 2012-05