drugset / Trial / NCT00935558
Dendritic Cell Based Therapy for Breast Cancer Patients
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary aim of this study is to investigate time to progression in breast cancer patients vaccinated with autologous dendritic cells pulsed with peptides in combination with adjuvant aromatase inhibitor (AI), Thymosin 1 alpha and interleukin-2. The secondary aim is to investigate whether a measurable immune response can be induced, and to evaluate the clinical effect (objective response rate) of the vaccination regime.
Timeline
- Start
- 2009-07
- Primary completion
- 2012-05
- Completion
- —
Publications
- Background Svane IM, Pedersen AE, Johansen JS, Johnsen HE, Nielsen D, Kamby C, Ottesen S, Balslev E, Gaarsdal E, Nikolajsen K, Claesson MH. Vaccination with p53 peptide-pulsed dendritic cells is associated with disease stabilization in patients with p53 expressing advanced breast cancer; monitoring of serum YKL-40 and IL-6 as response biomarkers. Cancer Immunol Immunother. 2007 Sep;56(9):1485-99. doi: 10.1007/s00262-007-0293-4. Epub 2007 Feb 7.
- Background Svane IM, Pedersen AE, Johnsen HE, Nielsen D, Kamby C, Gaarsdal E, Nikolajsen K, Buus S, Claesson MH. Vaccination with p53-peptide-pulsed dendritic cells, of patients with advanced breast cancer: report from a phase I study. Cancer Immunol Immunother. 2004 Jul;53(7):633-41. doi: 10.1007/s00262-003-0493-5. Epub 2004 Feb 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DC vaccine | Vaccine | 5e+06 cells | Other |
| Comparator | Anastrozole | Other / unclassified | 1 mg | Oral |
| Comparator | Exemestane | Small molecule | 25 mg | Oral |
| Comparator | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Background | Thymosin 1 alpha | Unknown | 1.6 mg | Subcutaneous |
| Background | aldesleukin | Protein / enzyme biologic | 6 unknown | Subcutaneous |