Her-2/Neu in Patients With Metastatic Breast Cancer (AdHERe)

Metastatic Breast Cancer Clinical Trial

— AdHERe  

Official title:

A Phase I Study Investigating Multiple Injections of Autologous CD34+ Derived Dendritic Cells Transduced With an Adenovirus Expressing Rat Her-2/Neu in Patients With Metastatic or Locally Recurrent Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162929
• Other study ID #: CTA-Control-092517
• Status: Completed
• Phase: Phase 1
• First received: September 10, 2005
• Last updated: May 31, 2012
• Start date: January 2005
• 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

The purpose of this study is to determine the maximum tolerated dose and/or maximum attainable dose of a vaccine consisting of human autologous dendritic cells transduced by an adenovector expressing rat Her-2/neu (AdHer-2/neu) in patients with metastatic breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• 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 fluorescence in-situ hybridization [FISH] +)

4. One of the following:

1. currently receiving hormonal therapy or are candidates for such, or

2. being considered for trastuzumab, or

3. cancer has progressed on trastuzumab.

Exclusion Criteria:

1. Pregnant or lactating women.

2. Prior or concurrent malignancies except for treated basal cell or squamous cell carcinoma of the skin or in situ cancer of the cervix or any other cancer treated and presumed cured for 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 × 10^9/L or lymphocytes < 1.0 × 10^9/L or platelets < 100 × 10^9/L.

6. Baseline liver enzymes (AST or ALT) greater than 3 times the upper limit of normal or greater than 5 times the upper limit of normal if liver metastases are present and/or bilirubin is greater than 50 mmol.

7. CD4 cells < 0.5 ×10^9/L

8. Patients with documented brain metastases.

9. Patients with any acute illness that would interfere with the collection of CD34+ cells or administration of vaccination cellular therapy (i.e. unstable angina, renal or liver failure, or severe chronic obstructive airway disease).

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 Juravinski Cancer Center and the Henderson site of the Hamilton Health Sciences.

14. Failure to give written informed consent.

15. Baseline left ventricular ejection fraction (LVEF) < 55% by echocardiography or multigated acquisition (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

Intervention

Biological:
• AdHer-2/neu transduced dendritic cells
Group 1 1 ×10'7 expanded cells (2.5 ×106 DCs per injection site) Group 2 5 ×10'7 expanded cells (1.25 ×107 DCs per injection site) Group 3 1 ×10'8 expanded cells (2.5 ×107 DCs per injection site)

Locations

Country	Name	City	State
n/a

Sponsors (3)

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

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