Chemo-Immunotherapy: Observational Trial of Carboplatin-pegylated Liposomal Doxorubicin (PLD) or Doxorubicin Combination Chemotherapy With Tocilizumab, a Humanized Monoclonal Antibody Against the Human Interleukin-6 (IL-6) Receptor, and Pegylated Interferon Alpha (Peg-Intron) for Patients With Recurrent Ovarian Cancer.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- The feasibility (NCI-CTCv4.0) to combine carboplatin and PLD or doxorubicin with tocilizumab as well as with tocilizumab and Peg-Intron
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven epithelial ovarian cancer
- •Progression of disease or relapse after previous therapy with platinum
- •Measurable disease (RECIST 1.1) or elevated CA125 > 2 times the upper normal limit (UNL) within 3 months and confirmed
- •Age ≥18 years
- •WHO performance status 0-2
- •Adequate bone marrow function: WBC ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
- •Adequate liver function: bilirubin ≤1.5 x UNL range, ALAT and/or ASAT
- •2.5 x UNL (<5x UNL in case of liver metastases), Alkaline Phosphatase ≤5 x UNL
- •Adequate renal function: the calculated creatinine clearance should be
- •50 mL/min
- •Survival expectation > 3 months
- •Patients must be accessible for treatment and follow-up
- •Written informed consent according to the local Ethics Committee requirements
排除标准
- •Chemotherapy within past 3 months
- •Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
- •Serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
- •Known hypersensitivity reaction to any of the components of the treatment
- •Pregnancy or lactating
- •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
- •Infection with tuberculosis and hepatitis B or C
研究组 & 干预措施
Group 1
Carboplatin/Caelyx
干预措施: Carboplatin and Caelyx or doxorubicin (Drug)
Group 2
Carboplatin/Caelyx or doxorubicin plus Tocilizumab
干预措施: tocilizumab and interferon alpha 2-b (Drug)
Group 2
Carboplatin/Caelyx or doxorubicin plus Tocilizumab
干预措施: Carboplatin and Caelyx or doxorubicin (Drug)
Group 3
Carboplatin/Caelyx or doxorubicin plus Tocilizumab plus Peg-Intron
干预措施: tocilizumab and interferon alpha 2-b (Drug)
Group 3
Carboplatin/Caelyx or doxorubicin plus Tocilizumab plus Peg-Intron
干预措施: Carboplatin and Caelyx or doxorubicin (Drug)
结局指标
主要结局
The feasibility (NCI-CTCv4.0) to combine carboplatin and PLD or doxorubicin with tocilizumab as well as with tocilizumab and Peg-Intron
时间窗: two years
The safety (NCI-CTCv4.0)and efficacy (immune-monitoring)of the new combination will be measured .
次要结局
- The effect of chemo-immunotherapy on the immune system(two years)
- The relation between anti-tumor immunity and clinical outcome(two years)
研究者
J.R. Kroep
MD, PhD
Leiden University Medical Center