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

NCT00307229 | Completed Phase 1

• 1 other identifier: CTA-Control-100643
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

metastatic breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

• toxicity

  Weeks 4, 6, 7, 10, 14, 18, 22, 26

Secondary Outcomes (1)

• tumour response

  Weeks 6, 18

Interventions

adenoviral vector encoding rat Her-2/neu BIOLOGICAL

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• metastatic or locally recurrent breast cancer,
• years of age or older,
• Her-2/neu positive (3+ by immunohistochemistry or FISH +),
• One of the following
• currently receiving hormonal therapy or are candidates for such or,
• being considered for trastuzumab or,
• their cancer has progressed on trastuzumab

You may not qualify if:

• Pregnant or lactating women.
• 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.
• Currently receiving chemotherapy, immunotherapy, adenoviral gene therapy or biological cancer therapy. \[Note: concurrent hormonal therapy (tamoxifen,aromatase inhibitors, or megace) is permitted.\].
• Treatment with trastuzumab within 4 weeks prior to first dose of vaccine therapy.
• Hemoglobin \< 80 g/L or granulocytes \< 1.5 x 109 /L or lymphocytes \< 1.0 x 109 /L or platelets \< 100 x 109 /L.
• 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.
• CD4 cells \< 0.5 x 109 /L
• Patients with documented brain metastases.
• Patients with any acute illness that would interfere with vaccination
• Any patients requiring concurrent immunosuppressive therapy (e.g. corticosteroids).
• Eastern Cooperative Oncology Group (ECOG) performance status of \> 2.
• Patients with a life expectancy of less than 6 months.
• Geographic inaccessibility which would preclude follow-up. Patients registered on the trial must be treated and followed at the Jewish General Hospital.
• Failure to give written informed consent.
• Baseline left ventricular ejection fraction (LVEF) \< 55% by echocardiography or MUGA scan.

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead
• Ontario Cancer Research Network: collaborator
• Canadian Breast Cancer Research Alliance: collaborator

Study Sites (1)

Sir Mortimer B. Davis - Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gerry Batist, M.D.

  Lady Davis Institute for Medical Research Jewish General Hospital

  STUDY CHAIR

• Ronan Foley, M.D.

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

• Mark Levine, M.D.

  Ontario Clinical Oncology Group (OCOG)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2006
• First Posted: March 27, 2006
• Study Start: March 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: May 1, 2012
• Last Updated: June 4, 2012

Record last verified: 2012-05

Locations

CA (1)