Her-2/Neu in Patients With Metastatic Breast Cancer (AdHERe)

This study has been completed.
Sponsor:
Collaborators:
Ontario Cancer Research Network
Canadian Breast Cancer Research Alliance
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00162929
First received: September 10, 2005
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Biological: AdHer-2/neu transduced dendritic cells
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study Investigating Multiple Injections of Autologous CD34+ Derived Dendritic Cells Transduced With an Adenovirus Expressing Rat Her-2/Neu in Patients With Metastatic or Locally Recurrent Breast Cancer

Resource links provided by NLM:


Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • toxicity [ Time Frame: weeks 4, 6, 7, 10, 14, 18, 22, 26 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • tumour response [ Time Frame: Weeks 6, 18 ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: January 2005
Study Completion Date: May 2012
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: AdHer-2/neu transduced dendritic cells
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Metastatic or locally recurrent breast cancer
  2. 18 years of age or older
  3. Her-2/neu positive (3+ by immunohistochemistry or fluorescence in-situ hybridization [FISH] +)
  4. One of the following:

    1. currently receiving hormonal therapy or are candidates for such, or
    2. being considered for trastuzumab, or
    3. cancer has progressed on trastuzumab.

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. 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.
  3. Currently receiving chemotherapy, immunotherapy, adenoviral gene therapy or biological cancer therapy. [Note: concurrent hormonal therapy (tamoxifen, aromatase inhibitors, or megace) is permitted.]
  4. Treatment with trastuzumab within 4 weeks prior to first dose of vaccine therapy.
  5. Hemoglobin < 80 g/L or granulocytes < 1.5 × 10^9/L or lymphocytes < 1.0 × 10^9/L or platelets < 100 × 10^9/L.
  6. 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.
  7. CD4 cells < 0.5 ×10^9/L
  8. Patients with documented brain metastases.
  9. 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).
  10. Any patients requiring concurrent immunosuppressive therapy (e.g. corticosteroids).
  11. Eastern Cooperative Oncology Group (ECOG) performance status of > 2.
  12. Patients with a life expectancy of less than 6 months.
  13. 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.
  14. Failure to give written informed consent.
  15. Baseline left ventricular ejection fraction (LVEF) < 55% by echocardiography or multigated acquisition (MUGA) scan.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162929

Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Ontario Cancer Research Network
Canadian Breast Cancer Research Alliance
Investigators
Study Chair: Sukhbinder Dhesy-Thind, M.D. Ontario Clinical Oncology Group; Juravinski Cancer Centre - Hamilton Health Sciences; McMaster University
Principal Investigator: 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)
  More Information

No publications provided

Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT00162929     History of Changes
Other Study ID Numbers: CTA-Control-092517
Study First Received: September 10, 2005
Last Updated: May 31, 2012
Health Authority: Canada: Health Canada

Keywords provided by Ontario Clinical Oncology Group (OCOG):
metastatic breast cancer
locally recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 31, 2014