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

Sponsor
Leiden University Medical Center
Study ID
NCT01637532
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Recurrent Ovarian Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tocilizumab and interferon alpha 2-b — DRUG
    During first three chemotherapy cycles, tocilizumab and/or Peg-Intron are added. Tocilizumab is given in a dose-escalation scheme (1,2,4,8mg/kg n=3) and Peg-Intron is adminstered subcutaneously 1.0ug/kg
  • Carboplatin and Caelyx or doxorubicin — DRUG
    Standard chemotherapeutic care given in every arm as standard care. A total of 6 cycles is the aim.

Study Details

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.

Key Dates

First listed
Jul 11, 2012
Start date
Feb 28, 2011
Status verified
Jan 2016
Primary completion
Sep 30, 2013
Completion
Sep 30, 2013

Study Design

Enrollment
21 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Group 1
    Carboplatin/Caelyx
  • Experimental: Group 2
    Carboplatin/Caelyx or doxorubicin plus Tocilizumab
  • Experimental: Group 3
    Carboplatin/Caelyx or doxorubicin plus Tocilizumab plus Peg-Intron

Primary Outcome Measure

The feasibility (NCI-CTCv4.0) to combine carboplatin and PLD or doxorubicin with tocilizumab as well as with tocilizumab and Peg-Intron [ Time Frame: two years ]

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