Feasibility of the Combination of Chemotherapy (Carbo/Caelyx or Carbo/Doxorubicin) With Tocilizumab (mAb IL-6R) and Peg-Intron in Patients With Recurrent Ovarian Cancer
Summary
The purpose of this interventional study is to determine the feasibility to combine standard chemotherapy (Carbo/Caelyx or doxorubicin) for recurrent ovarian cancer with immunotherapy (Tocilizumab and Peg-Intron). This study combines standard chemotherapy Carboplatin-Caelyx or doxorubicin with a monoclonal antibody against IL-6R (tocilizumab). High IL-6 levels correlate with poor prognosis and chemoresistance in ovarian cancer patients. In cases of chemoresistant ovarian cancer, therefore, modulation of the IL-6 pathway, by blocking the IL-6 receptor, may represent a promising strategy to both abolish drug resistance and amplify host immunity in patients with recurrent ovarian cancer. Blockade of the IL-6/IL-6R pathway may enhance immunogenic cell death and restore local normal DC maturation. In addition, the use of interferon-alpha (Peg-Intron) allows the full maturation of DC, thereby enhancing the anti-tumor response.
Timeline
- Start
- 2011-02
- Primary completion
- 2013-09
- Completion
- 2013-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tocilizumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Tocilizumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Tocilizumab | Monoclonal antibody | 4 mg/kg | Intravenous |
| Subject | Tocilizumab | Monoclonal antibody | 8 mg/kg | Intravenous |
| Subject | interferon alfa-2b | Protein / enzyme biologic | 1 ug/kg | Subcutaneous |
| Background | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Background | Doxorubicin | Other / unclassified | 30 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |