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

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:
NCT00307229
First received: March 24, 2006
Last updated: May 31, 2012
Last verified: May 2012
  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 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 Trial Investigating the Safety and Immunogenicity of an Adenovirus Encoding Rat HER-2 Administered Intradermally to 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: 8
Study Start Date: March 2006
Study Completion Date: May 2012
Primary Completion Date: July 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
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: NCT00307229

Locations
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
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 Corporation
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: NCT00307229     History of Changes
Other Study ID Numbers: CTA-Control-100643
Study First Received: March 24, 2006
Last Updated: May 31, 2012
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on September 18, 2014