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

NCT ID: NCT00307229

Last Updated: 2012-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2012-05-31

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.

Conditions

Metastatic Breast Cancer; Recurrent Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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)

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ontario Cancer Research Network

NETWORK

Sponsor Role: collaborator

Canadian Breast Cancer Research Alliance

OTHER

Sponsor Role: collaborator

Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerry Batist, M.D.

Role: STUDY_CHAIR

Lady Davis Institute for Medical Research Jewish General Hospital

Ronan Foley, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Corporation

Mark Levine, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ontario Clinical Oncology Group (OCOG)

Locations

Sir Mortimer B. Davis - Jewish General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

CTA-Control-100643

Identifier Type: -

Identifier Source: org_study_id