NCT01858155已完成1 期
Phase I Dose Finding Study for Melatonin in Pediatric Oncology Patients With Relapsed Solid Tumors
C17 Council5 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 5
- 主要终点
- Maximum tolerated daily dose of melatonin.
研究概览
简要总结
This study will evaluate dose escalation of melatonin in pediatric oncology patients with relapsed solid tumors. The purpose of this study is to determine the safety of melatonin at a dose up to 20 mg daily, as well as to determine the maximum tolerated dose of melatonin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be able to take medication by mouth either by swallowing, chewing or sublingual routes.
- •Patients must have a documented life expectancy of ≥ 8 weeks.
- •Patients must have histologic or radiographic evidence of a relapsed malignant solid tumor. Intrinsic brain stem tumors or optic pathway gliomas may be diagnosed by clinical and radiologic methods.
- •Patient, parent, legal representative and/or guardian must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
- •Minimum Weight Requirements: Dose level 1 - 22.2kg, Dose level 2 - 11.1kg, Dose level 3 - 5.6kg
- •Patients must be taking a stable dose (with no additions, modifications or deletions) of chemotherapy started ≥ 14 days prior study enrollment.
- •Prescribed Chemotherapy drug(s) must not be known to interact with melatonin
- •Adequate Bone Marrow Function Defined as:
- •Patients with solid tumors without bone marrow involvement:
- •Peripheral absolute neutrophil count (ANC) ≥ 1 x109/L
- •Platelet count ≥ 50 X 109/L (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment)
- •Hemoglobin ≥ 80 g/L (may receive RBC transfusions)
- •Patients with known bone marrow metastatic disease are eligible for study but not evaluable for hematologic toxicity.
- •Must not be known to be refractory to red cell or platelet transfusions.
- •These patients do not need to meet the bone marrow function requirements, as hematological toxicity will not be measured due to metastatic disease.
- •Adequate Liver Function Defined as:
- •Total Bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.
- •ALT ≤ 1.5 x ULN for age.
排除标准
- •Chemotherapy: Melatonin inhibits the action of doxorubicin
- •Growth factors that support white cell number administered ≤ 7 days prior to enrollment.
- •Patients requiring corticosteroids who are not on a stable or decreasing dose of corticosteroid for ≥ 14 days.
- •Patients prescribed immunosuppressant therapy that is not specifically utilized for chemotherapy purposes. Patient prescribed: Cyclosporine, Mycophenolate Mofetil HCL, Tacrolimus, Sirolimus and Azathioprine should be excluded
- •Patients prescribed anti-coagulation therapy (Warfarin, Low Molecular Weight Heparin (LMWH), or System Heparin Therapy)
- •Concomitant medications that are known CYP1A2 inhibitors interact with Melatonin.
- •Patients prescribed megace, corticosteroids and periactin started ≤ 14 days prior to study enrollment.
- •Patients taking the following medications: benzodiazepines, nifedipine, NSAID's, ASA and/or Beta Blockers
- •Patients ≤ 7 days post-operative from any surgical procedure.
- •Patients with any signs of active post-operative bleeding.
- •Patients with an infection that is not responding to anti-microbial therapy.
- •Any condition that would negatively impact effective gut absorption and/or swallowing of study medication.
- •Patients in the opinion of the investigator may not be able to comply with study protocol requirements
- •Patients already receiving melatonin are excluded from the study.
- •Allergies to the medicinal and/or non-medicinal ingredients of melatonin which include: Melatonin, Calcium Salicate, Croscarmellose Sodium, IsoMalt, Magnesium Stearate, Microcrystalline Cellulose.
- •As melatonin can cause fatigue, patients taking melatonin should refrain from driving or operating machinery within 5 hours of taking the melatonin.
研究组 & 干预措施
Melatonin
Experimental
干预措施: Melatonin (Drug)
结局指标
主要结局
Maximum tolerated daily dose of melatonin.
时间窗: 8 Weeks
次要结局
- Number of dose limiting toxicities during 8 weeks of melatonin therapy.(8 Weeks)
- Peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of Melatonin.(8 Weeks)
- The quantity of cytokines will be measured during 8 weeks of melatonin therapy.(8 Weeks)
- Change from Baseline in weight after 8 weeks of therapy.(8 Weeks)
研究者
研究点 (5)
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