Autologous Vaccination With Lethally Irradiated, Autologous Breast Cancer Cells Engineered to Secrete GM-CSF in Women With Operable Breast Cancer
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ClinicalTrials.gov Identifier: NCT00880464 |
Recruitment Status :
Completed
First Posted : April 13, 2009
Results First Posted : November 9, 2021
Last Update Posted : April 1, 2022
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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) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase Ib Study of Autologous Vaccination With Lethally Irradiated, Autologous Breast Cancer Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete GM-CSF Following Preoperative Chemotherapy in Women With Operable Breast Cancer |
Actual Study Start Date : | January 1, 2006 |
Actual Primary Completion Date : | October 2011 |
Actual Study Completion Date : | June 2021 |

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
Vaccination with autologous tumor cells engineered by adenoviral mediated gene transfer to secrete GM-CS |
- Minimum Number of Vaccine Doses Created Using Participant Tumor Sample [ Time Frame: 40 Months ]Tumor samples were obtained via malignant effusion or a surgically accessible tumor nodule of 2 cm in greatest diameter. Tumor cells were processed to single cell suspension and transduced with adenoviral vector encoding human Granulocyte-macrophage colony-stimulating factor (GM-CSF). Then, the cells washed extensively and irradiated with 10,000 cGy. Over the next 14 days, sterility cultures were tested for endotoxin and mycoplasma contamination. Individual vaccine cell dose and number varied depending on the final cell yield from vaccine production. For stage II-III patients, the minimal dose was 1 x 10^5 cells and the maximal dose was 4 x 10^6 cells. For metastatic patients, the minimal dose was 1 x 10^5 cells and the maximal dose was 1 x 10^7 cells.
- Number of Participants With Grade 3 or Higher Adverse Events [ Time Frame: Up to 58 Months ]Number of participants with grade 3 or higher adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Median Follow-up Time by Survival Status [ Time Frame: Up to 14 Years ]Participants followed for survival status. Participants who were alive were noted as such as late as December 2020.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed invasive breast cancer, pre-operative stages II-III per AJCC 6th edition, based on baseline evaluation by clinical examination and/or breast imaging
- Cohort 1: At least 2cm of residual disease in sum of diameters by clinical or radiographic findings following their preoperative chemotherapy
- Cohort 2: Patients who have not received preoperative chemotherapy must have at least 4cm of disease in the largest diameter by clinical or radiographic findings
- Prior therapy for Cohort 1 only: Must have completed preoperative (neoadjuvant) chemotherapy with either a standard regimen (containing an anthracycline and/or a taxane) or on a clinical trial
- HER2 positive tumors must have received at least one prior trastuzumab-based therapy, and may not receive concurrent trastuzumab therapy and vaccination
- Must initiate hormonal therapy (if indicated), including ovarian suppression, at least 4 weeks prior to initiation of vaccinations
- Must have completed definitive resection of primary tumor with adequated excision of gross disease. Surgery should have occured more than 28 days but within 12 weeks prior to enrollment
- May receive concurrent hormonal therapy, such as tamoxifen, ovarian suppression, and aromatase inhibitors
- Must have had prior banked tumor of sufficient cellular yield for vaccination
- ECOG Performance Status 0 or 1
- 18 years of age or older
- Greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy
- Adequate recovery from recent surgery and radiation therapy
Exclusion Criteria:
- Uncontrolled active infection or illness
- Other medical or psychiatric illness or social situation that would limit study compliance
- Pregnancy or nursing mothers
- Evidence of HIV infection
- Previous participation in an adenovirus-based trial
- Concurrent invasive malignancies

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): NCT00880464
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: | Ana C Garrido-Castro, Principal Investigator, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00880464 |
Other Study ID Numbers: |
08-216 |
First Posted: | April 13, 2009 Key Record Dates |
Results First Posted: | November 9, 2021 |
Last Update Posted: | April 1, 2022 |
Last Verified: | March 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
autologous vaccination GM-CSF adenoviral mediated gene transfer Stage IV breast cancer |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |