2024-517185-42-00招募中1 期
Phase 1 study of a Propranolol (HEMANGIOL®) and oral metronomic Vinorelbine (NAVELBINE®) combination on children and teenagers With Refractory/Relapsing Solid Tumors - PROVIN
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 7
- 主要终点
- Maximum tolerated dose (MTD) assessed over the first two treatment cycles (D1 to D56) according to the NCI-CTC v5.0 scale and defined as follows: - Grade 3 or 4 neutropenia requiring treatment deferral of more than 7 days - Grade 3 or 4 thrombocytopenia requiring transfusions for more than 7 days - Grade 3 or 4 non-hematological toxicity, with the exception of : - nausea and vomiting - grade 3 fever, - grade 3 liver toxicity reversible after 14 days
研究概览
简要总结
To determine the maximal tolerated dose of oral navelbine given 3 times a week with daily oral propanolol
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Histological diagnosis of malignancy or typical radiological appearance of a low-grade glial tumor not warranting biopsy or surgery, and desmoid tumors
- •No known allergy to any of the compounds in the experimental treatment
- •Able to swallow softgels and oral suspension or tablets
- •Life expectancy > 3 months
- •Affiliation to a social security scheme
- •Effective contraception (if applicable) throughout the treatment period. Women of childbearing potential must use effective contraception during treatment, and at least until 7 months after treatment. Men treated with Navelbine must be warned not to conceive a child during treatment, and must use effective contraception during treatment and at least until 4 months after treatment.
- •Having signed the informed consent form. For unemancipated minors, authorization will be given by the holders of parental authority. Minors will receive information adapted to their ability to understand.
- •Refractory or relapsed disease, in therapeutic failure despite standard treatments, or for which there is no effective standard therapy
- •Measurable lesions according to RECIST, INSS or WHO criteria depending on histological type
- •Age > or = 4 years and <24 years
- •Lansky score >50 or Karnofsky>50
- •Hematological conditions: neutrophils > 1 x 109/l and platelets > 75 x 109/l
- •Creatinine < 1.5 x upper limit of normal for age (ULN) or Schwarz clearance > 70 ml/ mn/1.73 m2
- •Liver function: Total Bilirubin < 1.5 LNS and SGOT and SGPT <3 LNS except in the case of liver metastases: Total Bilirubin < 3LNS and SGOT and SGPT <5 LNS
- •Absence of other organ toxicity (Grade < 2 according to NCI-CTC v5.0)
排除标准
- •Chemotherapy within 21 days prior to D1 of the start of study treatment. This period may be shortened in the case of vincristine treatment (2 weeks) and extended to 6 weeks in the case of nitrosourea treatment or 5 half-lives in the case of targeted therapies or metronomic chemotherapy.
- •Contraindications to navelbine: pathologies affecting absorption of the treatment, notably a history of surgical resection of the stomach, patients on long-term oxygen therapy, vaccination against yellow fever
- •Inflammatory bowel disease
- •Pregnant or breast-feeding women
- •Organ toxicity grade > 2 according to NCI-CTCAE scale version 5.0
- •Active infection
- •Inability to undergo medical follow-up for geographical, social or psychological reasons
- •Radiotherapy within 3 months prior to D1 of the start of study treatment. RT on a non-target lesion is permitted up to 3 weeks before inclusion.
- •Previous treatment with oral or IV vinorelbine in a metronomic regimen
- •High blood pressure during treatment.
- •None hypersensibility to any of the investigational drugs, including their respective excipients
- •Contraindications to propranolol (asthma or history of bronchospasm, Prinzmetal's angina, severe peripheral arterial disorders, Raynaud's syndrome, arterial hypotension (age-dependent limits), second- or 3rd-degree AVB, sinus disease including sino-auricular block, bradycardia with age-dependent limits, cardiogenic shock, heart failure not controlled by treatment, diabetes/predisposition to hypoglycemia, untreated pheochromocytoma, chronic obstructive bronchitis, history of anaphylactic reaction, as part of primary and secondary prevention of digestive bleeding in cirrhotics: advanced liver failure with hyperbilirubinemia, massive ascites, hepatic encephalopathy)
结局指标
主要结局
Maximum tolerated dose (MTD) assessed over the first two treatment cycles (D1 to D56) according to the NCI-CTC v5.0 scale and defined as follows: - Grade 3 or 4 neutropenia requiring treatment deferral of more than 7 days - Grade 3 or 4 thrombocytopenia requiring transfusions for more than 7 days - Grade 3 or 4 non-hematological toxicity, with the exception of : - nausea and vomiting - grade 3 fever, - grade 3 liver toxicity reversible after 14 days
Maximum tolerated dose (MTD) assessed over the first two treatment cycles (D1 to D56) according to the NCI-CTC v5.0 scale and defined as follows: - Grade 3 or 4 neutropenia requiring treatment deferral of more than 7 days - Grade 3 or 4 thrombocytopenia requiring transfusions for more than 7 days - Grade 3 or 4 non-hematological toxicity, with the exception of : - nausea and vomiting - grade 3 fever, - grade 3 liver toxicity reversible after 14 days
次要结局
- Tolerance judged using NCI-CTC v5.0 scale
- PK performed by liquid chromatography coupled with either mass spectrometry (LCMSMS) or UV detection
- Efficacy: Progression-free survival 2, 4, 6, 12, 18 and 24 months of treatmentand overall survival after 6, 12, 18 and 24 months of treatment, and response rate according to RECIST, SIOPEN or WHO criteria. PFS will be calculated from study entry to the date of progression or death (if related to tumor or treatment toxicities). Overall survival will be calculated from study entry to date of death.
研究者
Prof. Nicolas ANDRE
Scientific
Centre Hospitalier Regional De Marseille
研究点 (7)
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