EUCTR2013-001005-82-IT进行中（未招募）1 期
Phase II trial of intraperitoneal MHC unrestricted adoptive cell therapy with TALL-104 cells in patients with ovarian carcinoma with minimal or microscopic residual disease at second look laparotomy/laparoscopy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •-Diagnosis of ovarian carcinoma FIGO stage IIIA and IIIB/IIIC/IV
- •-Patients not eligible for treatment with Bevacizumab
- •-Minimal or microscopic residual disease at second look laparotomy/laparoscopy (patients with extra-abdominal disease will be excluded by the study unless those with pleural effusion). Microscopic residual disease is defined as positive cytology washing and/or positive random biopsies at 2nd look, while minimal residual disease is defined as tumour lesion/lesions of diameter < 0.5 cm at 2nd look.
- •-Written Informed Consent.
- •-Patients will be selected as follows:
- •?-Patients who signed the Informed Consent Form and considered eligible to 2nd look laparoscopy because have no clinical evidence of disease (negative CT scan and negative pelvic exam) during the screening phase.
- •?-Patients who underwent 2nd laparotomy and who accept to provide signed Informed Consent Form to use the collected histology/cytology samples.
- •-Age 18 to 75 years.
- •-P.S.: ? 2 (WHO scale).
- •-First line treatment including Platinum compounds and Paclitaxel.
- •-Second look laparotomy/laparoscopy performed not more than 8 weeks before day 1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. Evidence of extraperitoneal metastatic disease.
- •2. Clinically significant cardiovascular, hepatic, gastrointestinal, haematological or psychiatric diseases as judged by the Investigator.
- •3. HIV infection.
- •4. Medical conditions requiring steroid administration.
- •5. Chemotherapy within the previous four weeks.
- •6. Serum Creatinine > 1.5 mg/dl.
- •7. Absolute neutrophil count < 1,500/mm3 and platelets < 100,000/mm3 .
- •8. Use of other investigational drugs/treatments, or enrolment in a clinical study within the previous 3 months.
研究者
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