Phase 1
Completed N=7
Autologous Vaccination With Lethally Irradiated, Autologous Breast Cancer Cells Engineered to Secrete GM-CSF in Women With Operable Breast Cancer
Source: ClinicalTrials.gov NCT00880464 ↗Enrolled (actual)
7
Serious AEs
14.3%
Results posted
Nov 2021
Primary outcomePrimary: Minimum Number of Vaccine Doses Created Using Participant Tumor Sample — 6 doses
Summary
The purpose of this trial is to test the safety of a vaccine made from a patient's own breast cancer cells, and determine if this vaccine will delay or stop the growth of the cancer. The vaccine is made by genetically modifying a patient's own tumor cells to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF) to activate the immune response
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Minimum Number of Vaccine Doses Created Using Participant Tumor Sample |
6 | — |
| PRIMARY Number of Participants With Grade 3 or Higher Adverse Events |
1; 0; 0 | — |
| SECONDARY Median Follow-up Time by Survival Status |
9.88; 6.24 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00880464). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.