Clinical trial NCT00307229: Adenovirus Encoding Rat HER-2 in Patients With Metastatic Breast Cancer (AdHER2.1)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Breast Cancer
Recurrent Breast Cancer
Keywords: metastatic breast cancer
recurrent breast cancer
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Ontario Cancer Research Network
name: Canadian Breast Cancer Research Alliance
First posted: 2006-03-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: toxicity
timeFrame: Weeks 4, 6, 7, 10, 14, 18, 22, 26
Secondary outcomes:
measure: tumour response
timeFrame: Weeks 6, 18
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis - Jewish General Hospital
state: Quebec
Study officials:
affiliation: Lady Davis Institute for Medical Research Jewish General Hospital
name: Gerry Batist, M.D.
role: STUDY_CHAIR
affiliation: Hamilton Health Sciences Corporation
name: Ronan Foley, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ontario Clinical Oncology Group (OCOG)
name: Mark Levine, M.D.
role: PRINCIPAL_INVESTIGATOR
References: