drugset / Trial / NCT01637532

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

NCT01637532

Non-randomizedParallel-groupOpen-labelTreatment

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

EvaluationDrugModalityDoseRoute
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

Indications