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Adenovirus Encoding Rat HER-2 in Patients With Metastatic Breast Cancer (AdHER2.1)

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. Identifier: NCT00307229
Recruitment Status : Completed
First Posted : March 27, 2006
Last Update Posted : June 4, 2012
Ontario Cancer Research Network
Canadian Breast Cancer Research Alliance
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic Breast Cancer Recurrent Breast Cancer Biological: adenoviral vector encoding rat Her-2/neu Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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)

Primary Outcome Measures :
  1. toxicity [ Time Frame: Weeks 4, 6, 7, 10, 14, 18, 22, 26 ]

Secondary Outcome Measures :
  1. tumour response [ Time Frame: Weeks 6, 18 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00307229

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Canada, Quebec
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Ontario Cancer Research Network
Canadian Breast Cancer Research Alliance
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Study Chair: Gerry Batist, M.D. Lady Davis Institute for Medical Research Jewish General Hospital
Principal Investigator: Ronan Foley, M.D. Hamilton Health Sciences Corporation
Principal Investigator: Mark Levine, M.D. Ontario Clinical Oncology Group (OCOG)
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Responsible Party: Ontario Clinical Oncology Group (OCOG) Identifier: NCT00307229    
Other Study ID Numbers: CTA-Control-100643
First Posted: March 27, 2006    Key Record Dates
Last Update Posted: June 4, 2012
Last Verified: May 2012
Keywords provided by Ontario Clinical Oncology Group (OCOG):
metastatic breast cancer
recurrent breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases