Adenovirus Encoding Rat HER-2 in Patients With Metastatic... | NCT00307229

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

NCT00307229

Sponsor

Ontario Clinical Oncology Group (OCOG)

Status

Completed

Last Update Posted

Jun 4, 2012Estimated

Enrollment

8Actual

Phase

Phase 1

Conditions

Metastatic Breast Cancer
Recurrent Breast Cancer

Interventions

adenoviral vector encoding rat Her-2/neu

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Jul 2009Actual

Completion Date

May 2012Actual

First Submitted Date

Mar 24, 2006

First Submission Date that Met QC Criteria

Mar 24, 2006

First Posted Date

Mar 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2012

Last Update Posted Date

Jun 4, 2012Estimated

Name	Class
Ontario Cancer Research Network	NETWORK
Canadian Breast Cancer Research Alliance	OTHER

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Name	Type	Description	Arm Group Labels	Other Names
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)

Measure	Description	Time Frame
toxicity		Weeks 4, 6, 7, 10, 14, 18, 22, 26

Measure	Description	Time Frame
tumour response		Weeks 6, 18

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

metastatic or locally recurrent breast cancer,
18 years of age or older,
Her-2/neu positive (3+ by immunohistochemistry or FISH +),
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:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sir Mortimer B. Davis - Jewish General Hospital		Montreal	Quebec	H3T 1E2	Canada

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases