Her-2/Neu in Patients With Metastatic Breast Cancer (AdHERe) (AdHERe)
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|ClinicalTrials.gov Identifier: NCT00162929|
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : June 4, 2012
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|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer||Biological: AdHer-2/neu transduced dendritic cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||May 2012|
- 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)
- toxicity [ Time Frame: weeks 4, 6, 7, 10, 14, 18, 22, 26 ]
- tumour response [ Time Frame: Weeks 6, 18 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Metastatic or locally recurrent breast cancer
- 18 years of age or older
- Her-2/neu positive (3+ by immunohistochemistry or fluorescence in-situ hybridization [FISH] +)
One of the following:
- currently receiving hormonal therapy or are candidates for such, or
- being considered for trastuzumab, or
- cancer has progressed on trastuzumab.
- Pregnant or lactating women.
- 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.
- 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 × 10^9/L or lymphocytes < 1.0 × 10^9/L or platelets < 100 × 10^9/L.
- 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.
- CD4 cells < 0.5 ×10^9/L
- Patients with documented brain metastases.
- 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).
- 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 Juravinski Cancer Center and the Henderson site of the Hamilton Health Sciences.
- Failure to give written informed consent.
- Baseline left ventricular ejection fraction (LVEF) < 55% by echocardiography or multigated acquisition (MUGA) scan.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162929
|Study Chair:||Sukhbinder Dhesy-Thind, M.D.||Ontario Clinical Oncology Group; Juravinski Cancer Centre - Hamilton Health Sciences; McMaster University|
|Principal Investigator:||Ronan Foley, M.D.||McMaster University|
|Principal Investigator:||Richard Tozer, M.D.||Juravinski Cancer Centre - Hamilton Health Sciences|
|Principal Investigator:||Peter Ellis, M.D.||Juravinski Cancer Centre - Hamilton Health Sciences|
|Principal Investigator:||Jack Gauldie, M.D.||McMaster University|
|Principal Investigator:||Mark Levine, M.D.||Ontario Clinical Oncology Group (OCOG)|
|Responsible Party:||Ontario Clinical Oncology Group (OCOG)|
|Other Study ID Numbers:||
|First Posted:||September 13, 2005 Key Record Dates|
|Last Update Posted:||June 4, 2012|
|Last Verified:||May 2012|
metastatic breast cancer
locally recurrent breast cancer
Neoplasms by Site