Vaccination With Autologous Breast Cancer Cells Engineered to Secrete Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Metastatic Breast Cancer Patients
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ClinicalTrials.gov Identifier: NCT00317603 |
Recruitment Status
:
Active, not recruiting
First Posted
: April 25, 2006
Last Update Posted
: March 3, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Biological: Autologous, Lethally Irradiated Breast Cancer Cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Trial of Vaccination With Autologous, Lethally Irradiated Breast Cancer Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Granulocyte-Macrophage Colony Stimulating Factor in Metastatic Breast Cancer Patients |
Study Start Date : | November 2005 |
Estimated Primary Completion Date : | December 2017 |
Estimated Study Completion Date : | December 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Vaccine
Vaccinations will be administered on days 1,8,15 and every two weeks thereafter until the supply of vaccine has been exhausted or the patient is removed from study. As indicated in 5.2.5, vaccine cell dosage will be approximately 1x10 7 , 4x10 6 , 1x10 6 , or 1x10 5 depending on the final cell yield. |
Biological: Autologous, Lethally Irradiated Breast Cancer Cells
Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out
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- To determine the doses of lethally irradiated, autologous breast cancer cells engineered by adenoviral mediated gene transfer to secrete GM-CSF that can be manufactured in patients with metastatic breast cancer [ Time Frame: 3 years ]
- to determine the safety and biologic activity of this vaccination in metastatic breast cancer patients [ Time Frame: 3 years ]
- To determine the time to progression and overall survival of metastatic breast cancer patients treated with this vaccine

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed Stage IV breast cancer
- Prior banked malignant effusion or significant malignant effusion for tumor harvest or surgically-accessible tumor nodule of at least 2cm in greatest diameter by physical exam, magnetic resonance imaging (MRI) or computed tomography (CT) scan
- Must have received at least one prior regimen of chemotherapy for metastatic disease
- Patients with HER2 positive tumors must have received at least one prior trastuzumab-based therapy in the metastatic setting, and may not receive trastuzumab therapy and vaccine treatment concurrently
- Patients may receive concurrent bisphosphonate therapy and/or erythropoetin therapy at any point while on study
- ECOG performance status 0 or 1
- Estimated life expectancy of greater than or equal to 6 months
- 18 years of age or older
- Greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy
- Adequate recovery from drug-related toxicities from prior systemic therapies
- Adequate recovery from recent surgery and radiation therapy
- Greater than 6 months since bone marrow or peripheral blood stem cell transplant
Exclusion Criteria:
- Urgent need for cytotoxic chemotherapy, radiotherapy, or surgery in the next 60 days
- Uncontrolled active infection or illness
- Psychiatric illness/social situation that would limit study compliance
- Pregnant or nursing mothers
- Evidence of HIV infection
- Previous participation in an adenovirus-based trial
- Concurrent invasive malignancy

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): NCT00317603
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Beth Overmoyer, MD | Dana-Farber Cancer Institute |
Responsible Party: | Beth Overmoyer, MD, Principal Investigator, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00317603 History of Changes |
Other Study ID Numbers: |
05-111 |
First Posted: | April 25, 2006 Key Record Dates |
Last Update Posted: | March 3, 2017 |
Last Verified: | March 2017 |
Keywords provided by Beth Overmoyer, MD, Dana-Farber Cancer Institute:
autologous vaccination GM-CSF adenoviral mediated gene transfer Stage IV breast cancer |
Additional relevant MeSH terms:
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |