Clinical trial · Interventional
Immunotherapy in Treating Patients With Metastatic Breast Cancer
A Phase I/II Study of Active Immunotherapy With Carcinoembryonic Antigen RNA-Pulsed, Autologous Cultured Dendritic Cells for Patients With Breast Cancer Who Achieve a Complete Response After High Dose Chemotherapy and Stem Cell Support
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
RATIONALE: Immunotherapy using CEA-treated white blood cells may help a person's body build an immune response to and kill their tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of immunotherapy with CEA-treated white blood cells in treating patients with metastatic breast cancer who have achieved a partial or complete response after chemotherapy and peripheral stem cell transplantation.
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 |
|---|---|---|---|
| carcinoembryonic antigen RNA-pulsed DC cancer vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- carcinoembryonic antigen RNA-pulsed DC cancer vaccine
- description
- carcinoembryonic antigen RNA-pulsed DC cancer vaccine
- interventionNames
- Biological: carcinoembryonic antigen RNA-pulsed DC cancer vaccine
Primary outcomes (1)
- measure
- Evaluate the ability of active immunotherapy with carcinoembryonic antigen (CEA) RNA pulsed dendritic cells to induce CEA specific T cells in patients with metastatic breast cancer in complete remission following peripheral blood stem cell transplant.
- timeFrame
- Following administration of 4 IV vaccine doses (1 vaccine administered every 3 weeks)
Secondary outcomes (1)
- measure
- Determine the clinical efficacy in terms of overall and recurrence free survival of immunotherapy with CEA RNA pulsed dendritic cells in this patients population.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic breast cancer that expresses carcinoembryonic antigen (CEA) * At least 25% of the tumor cells must stain positive for CEA with at least moderate intensity * Must have achieved either partial response or complete response after high dose chemotherapy and peripheral blood stem cell transplant * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Menopausal status: * Not specified Performance status: * Karnofsky 70-100% Life expectancy: * Greater than 6 months Hematopoietic: * Absolute neutrophil count at least 1000/mm\^3 * Absolute lymphocyte count at least 1000/mm\^3 * Hemoglobin at least 9 mg/dL * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL * No serious ongoing chronic or acute hepatic disease Renal: * Creatinine less than 2.5 mg/dL Cardiovascular: * No serious ongoing chronic or acute cardiac disease (New York Heart Association class III or IV) Pulmonary: * No serious ongoing chronic or acute pulmonary illness such as asthma, chronic obstructive pulmonary disease, or radiation or drug induced pneumonitis Other: * No other prior or concurrent malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer within the past 5 years * No history of autoimmune disease such as inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis * No inflammatory bowel condition such as active infectious enteritis or eosinophilic enteritis * No active acute or chronic infection such as urinary tract infection, HIV, or viral hepatitis * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No concurrent immunotherapy Chemotherapy: * See Disease Characteristics * No concurrent chemotherapy Endocrine therapy: * At least 4 weeks since steroids * No concurrent steroid therapy Radiotherapy: * No concurrent radiotherapy Surgery: * Not specified Other: * No concurrent immunosuppressive agents such as azathioprine or cyclosporine A
References
Publications (0)
Data not yet available