Clinical trial · Observational
Safety Study of Cancer Stem Cell Vaccinie to Treat Breast Cancer
Study of Cancer Stem Cell Vcccinie That as a Specific Antigen in Metastatic Adenocarcinoma of the Breast
- 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)
Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors into immunosuppressed mice, preventing an assessment on the immunologic interactions and effects of CSCs. In this study, the investigators examined the vaccination effects produced by CSC-enriched populations from histologically distinctmurine tumors after their inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic and more effective as an antigen source than unselected tumor cells in inducing protective antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed antibodies and T cells were capable of selective targeting CSCs and conferring antitumor immunity.
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 |
|---|---|---|---|
| Neoplasms, Breast | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- non-vaccine
- label
- giving low vaccine
- label
- giving middle vaccine
- label
- giving high vaccine
Primary outcomes (1)
- measure
- The primary study purpose to determine the safety of immunization with cancer stem cells vaccinie by the number of participants with adverse events
- timeFrame
- up to 3 months
Secondary outcomes (1)
- measure
- The secondary objectives are to evaluate vaccinie immune responses to the immunizations by the data of body measurements
- timeFrame
- 1 month
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * The patient is ≥ 30 years of age at the time the informed consent to screening has been obtained; * The patient has one of the following histologically confirmed breast cancer subtypes: Estrogen receptor and/or progesterone positive tumor; Human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer; HER2-negative breast cancer. \-- The patient shows normal organ function according to the following parameters(as measured within six weeks prior to treatment allocation): * Hemoglobin: Within normal range according to institutional standards; * Absolute leukocyte count: Within normal range according to institutional standards; * Absolute lymphocyte count: Within normal range according to institutional standards; * Platelet count: Within normal range according to institutional standards; * Alanine aminotransferase: ≤ 2.5 x Upper Limit of Normal (ULN); * Aspartate aminotransferase: ≤ 2.5 x ULN; * Total bilirubin: ≤ 1.5 x ULN. In the case of known Gilbert's syndrome ≤ 2 x ULN; * Serum creatinine: 1.5 x ULN; * Calculated creatinine clearance: \> 50 mL/min . Exclusion Criteria: * The patient has inflammatory breast cancer, which is defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion. * Diagnosis established by incisional biopsy. * Prior and concomitant neoadjuvant anti-breast-cancer treatments such as chemotherapy, immunotherapy / biological response modifiers, endocrine therapy, and radiotherapy, unless authorized specifically by the protocol. * level 3 hypertension; * severe coronary disease; * myelosuppression; * respiratory disease; * brain metastasis; * chronic infections
References
Publications (1)
- RESULTNing N, Pan Q, Zheng F, Teitz-Tennenbaum S, Egenti M, Yet J, Li M, Ginestier C, Wicha MS, Moyer JS, Prince ME, Xu Y, Zhang XL, Huang S, Chang AE, Li Q. Cancer stem cell vaccination confers significant antitumor immunity. Cancer Res. 2012 Apr 1;72(7):1853-64. doi: 10.1158/0008-5472.CAN-11-1400. PMID 22473314