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

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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