Clinical trial · Interventional
Vaccination With Autologous Breast Cancer Cells Engineered to Secrete Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Metastatic Breast Cancer Patients
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
NCT00317603CI-TRIAL-00057487completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous, Lethally Irradiated Breast Cancer Cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vaccine
- description
- 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.
- interventionNames
- Biological: Autologous, Lethally Irradiated Breast Cancer Cells
Primary outcomes (1)
- measure
- Minimum Number of Vaccine Doses Created Using Participant Tumor Sample
- timeFrame
- Vaccine doses created and banked soon after registration, up to 8 days.
- description
- 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. The minimal dose was 1 x 10\^5 cells and the maximal dose was 1 x 10\^7 cells.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAnderson KS, Erick TK, Chen M, Daley H, Campbell M, Colson Y, Mihm M, Zakka LR, Hopper M, Barry W, Winer EP, Dranoff G, Overmoyer B. The feasibility of using an autologous GM-CSF-secreting breast cancer vaccine to induce immunity in patients with stage II-III and metastatic breast cancers. Breast Cancer Res Treat. 2022 Jul;194(1):65-78. doi: 10.1007/s10549-022-06562-y. Epub 2022 Apr 28. PMID 35482127