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Adenovirus Encoding Rat HER-2 in Patients With Metastatic Breast Cancer (AdHER2.1)
This study is currently recruiting participants.
Verified by Ontario Clinical Oncology Group (OCOG), June 2008
Sponsors and Collaborators: Ontario Clinical Oncology Group (OCOG)
Ontario Cancer Research Network
Canadian Breast Cancer Research Alliance
Information provided by: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT00307229
  Purpose

To determine the maximum tolerated dose and/or maximum attainable dose of a vaccine consisting of adenovector expressing rat Her-2/neu in patients with metastatic or locally recurrent breast cancer.


Condition Intervention Phase
Metastatic Breast Cancer
Recurrent Breast Cancer
Biological: adenoviral vector encoding rat Her-2/neu
Phase I

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase I Trial Investigating the Safety and Immunogenicity of an Adenovirus Encoding Rat HER-2 Administered Intradermally to Patients With Metastatic or Locally Recurrent Breast Cancer

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 ]

Estimated Enrollment: 18
Study Start Date: March 2006
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: adenoviral vector encoding rat Her-2/neu
    Group 1 1 x 10'7 pfu (2.5 X 10'6 pfu per injection site)(1.6 x 10'9 particles) Group 2 5 x 10'7 pfu (1.25 X 10'7 pfu per injection site)(8.0 x10'9 particles) Group 3 1 x 10'8 pfu (5 x 10'7 pfu per injection site)(1.6 x10'10 particles)
  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 FISH +),
  4. One of the following

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

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. Prior or concurrent malignancies except treated basal cell or squamous carcinoma of the skin or in situ cancer of the cervix or any other cancer treated and presumed cured 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 x 109 /L or lymphocytes < 1.0 x 109 /L or platelets < 100 x 109 /L.
  6. Baseline liver enzymes (AST or ALT) greater than 3 times upper limit of normal or greater than 5 times upper limit of normal if liver metastases present and/or bilirubin greater than 50 mmol.
  7. CD4 cells < 0.5 x 109 /L
  8. Patients with documented brain metastases.
  9. Patients with any acute illness that would interfere with vaccination
  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 Jewish General Hospital.
  14. Failure to give written informed consent.
  15. Baseline left ventricular ejection fraction (LVEF) < 55% by echocardiography or MUGA scan.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307229

Contacts
Contact: Lorraine Weise-Kelly, Ph.D. 905-527-2299 ext 43772 kellyla@mcmaster.ca
Contact: Anita Polgar 905-527-2299 ext 42648 polgara@mcmaster.ca

Locations
Canada, Quebec
Sir Mortimer B. Davis - Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Sub-Investigator: Michael Pollak, M.D.            
Sub-Investigator: Francois Patenaude, M.D.            
Sub-Investigator: Lawrence C Panasci, M.D.            
Sub-Investigator: Wilson H Miller, M.D.            
Sub-Investigator: David Malnychuk, M.D.            
Sub-Investigator: Adrian Langleben, M.D.            
Sub-Investigator: Victor Cohen, M.D.            
Principal Investigator: Gerald Batist, M.D.            
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Ontario Cancer Research Network
Canadian Breast Cancer Research Alliance
Investigators
Study Chair: Gerry Batist, M.D. Lady Davis Institute for Medical Research Jewish General Hospital
Principal Investigator: Ronan Foley, M.D. Hamilton Health Sciences
Principal Investigator: Mark Levine, M.D. Ontario Clinical Oncology Group
  More Information

Responsible Party: Ontario Clinical Oncology Group ( Dr. Mark Levine/Director OCOG )
Study ID Numbers: CTA-Control-100643
Study First Received: March 24, 2006
Last Updated: June 11, 2008
ClinicalTrials.gov Identifier: NCT00307229  
Health Authority: Canada: Health Canada

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

Study placed in the following topic categories:
Skin Diseases
Adenoviridae Infections
Breast Neoplasms
Breast Diseases
Recurrence

Additional relevant MeSH terms:
Disease Attributes
Neoplasms
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009