Phase 1
Completed N=15
Vaccination With Autologous Breast Cancer Cells Engineered to Secrete Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Metastatic Breast Cancer Patients
Source: ClinicalTrials.gov NCT00317603 ↗Enrolled (actual)
15
Serious AEs
25.0%
Results posted
Oct 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 | — |
| SECONDARY Number of Participants With Grade 3 or Higher Adverse Events |
0; 0; 0 | — |
| SECONDARY Number of Participants With RECIST Criteria Responses |
8; 2; 1; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00317603). 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.