2023-510251-31-00招募中2 期
A phase II study on adjuvant vaccination with dendritic cells loaded with autologous tumor homogenate in resected stage IV rare cancers: neuroendocrine tumors (NET) and soft tissue sarcoma (STS).
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月17日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of patients experiencing grade 3 or higher adverse events
研究概览
简要总结
Safety and immunological efficacy
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologically confirmed stage IV NeuroEndocrine Tumors (NET) or Soft Tissue Sarcoma (STS), surgically treated with radical intent.
- •Female patients of childbearing potential and all male patients must accept and be compliant with an highly effective contraceptive method (i.e. with a failure rate of <1% per year: double barrier method, one barrier method plus spermicidal, intrauterine device, or oral contraception) from informed consent signature and up to three months after end of study. For this purpose are considered of childbearing potential all female subjects after puberty unless they are post-menopausal for at least two years or are surgically sterile. Complete abstinence from sexual intercourses is acceptable if the patients’ lifestyle guarantees his/her strict compliance with this prescription in the judgement of the Investigator.
- •The patient is willing and able to give written informed consent for the study
- •The autologous surgical specimen must have been collected and sent to the Somatic Cell Therapy Lab of IRCCS IRST and must fulfil all the acceptance criteria prescribed by the GMP procedures.
- •The patient must be disease-free, as assessed by CT scan or MRI of the chest, abdomen, pelvis performed within 60 days before enrolment. If the resected lesions occurred in other sites, these must be also included in the baseline CT scan and in all the subsequent evaluations.
- •Patients disease-free candidates for only observation as per clinical practice (no standard treatment is available after surgery)
- •The patient must have recovered (grade 1 or less by CTCAE 5.0) from all the adverse events related to previous surgery.
- •Age ≥18 years
- •ECOG performance status 0 or 1
- •Patient must have acceptable organ function, defined as: a. Haemoglobin >10 g/dl b. White blood cells ≥3000/μl. c. Absolute neutrophil count ≥1500/μl. d. Platelets≥75000/μl. e. AST and ALT <3 times the upper institutional reference level. f. Total bilirubin <1.5 times the upper institutional reference level. g. Serum creatinine <1.5 times the upper institutional reference level.
- •Patients aged 70 years or older must have left ventricular ejection fraction not lower than 55% as assessed by echocardiography
排除标准
- •Patients with residual disease after surgery. Marginal resection of any lesion in the absence of clinically evident residual disease is acceptable.
- •Any uncontrolled serious intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations potentially impacting patient safety and compliance in the opinion of the Investigator
- •Refusal of giving written informed consent
- •Patient who completed surgery more than 90 days before study enrolment.
- •History of other neoplastic diseases in the previous 5 years, except basal cell carcinoma of the skin and in situ carcinoma of the cervix uteri treated with curative surgery
- •History of congenital or acquired immunodeficiency, including history of organ transplantation.
- •Female patients who are pregnant or breastfeeding.
- •Any positivity for the serologic markers of HBV (including at least anti-HBs antibodies and anti-HBc antibodies), HCV, HIV or Treponema pallidum. The serologic tests must have been performed within 30 days before any GMP-regulated activity (i.e. surgical resection and leukoaphaeresis). The sole positivity for antibodies against the HBV S antigen (i.e. with all other HBV markers negative) is indicative of previous HBV vaccination and therefore is acceptable
- •Participation in another clinical trial with any investigational agent within 30 days prior to study screening
- •Any active inflammatory or autoimmune disease requiring systemic steroids or other immunomodulatory agents as detailed in section 6.4, or potentially requiring such treatments during the study treatment in the judgement of the Investigator
- •Any clinical condition that, in the opinion of the Investigator or the Transfusion Medicine specialist, is a contraindication to leukaphaeresis. In addition, all patients aged 70 or older must be evaluated by a cardiology specialist before the procedure to exclude any clinically relevant cardiac condition and any grade 3-4 cardiac arrhythmia, even if asymptomatic.
结局指标
主要结局
Proportion of patients experiencing grade 3 or higher adverse events
Proportion of patients experiencing grade 3 or higher adverse events
Number of patients showing enhancement in the proportion of circulating immune effectors specific for a selected panel of associated antigens for each disease
Number of patients showing enhancement in the proportion of circulating immune effectors specific for a selected panel of associated antigens for each disease
次要结局
- Overall survival; relapse-free survival
- Proportion of patients with positive DHT test will be calculated and the predictive role will be analyzed taking account of the relationship with the primary and the other secondary outcomes
- All the immunological objectives will be calculated in terms of proportion and the correlation with efficacy and safety parameters will be explored
研究者
Laura Ridolfi
Scientific
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
研究点 (1)
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