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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307229
• Other study ID #: CTA-Control-100643
• Status: Completed
• Phase: Phase 1
• First received: March 24, 2006
• Last updated: May 31, 2012
• Start date: March 2006
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 2012
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer
• Recurrent Breast Cancer

Intervention

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)

Locations

Country	Name	City	State
Canada	Sir Mortimer B. Davis - Jewish General Hospital	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Canadian Breast Cancer Research Alliance, Ontario Cancer Research Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	toxicity		Weeks 4, 6, 7, 10, 14, 18, 22, 26	Yes
Secondary	tumour response		Weeks 6, 18	No