A Phase I Study of Doxercalciferol in Recurrent Pediatric Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD)
研究概览
简要总结
The goal of this clinical research study is to find the highest tolerable dose of doxercalciferol that can be given to pediatric patients with relapsed solid tumors. The safety of this drug will also be studied. Another goal is to measure the effect of the study drug on the blood levels of calcium and vitamin D.
详细描述
The Study Drug:
Doxercalciferol is designed to "copy the actions" of Vitamin D without causing blood levels of calcium to be too high.
Study Drug Dose Level:
If you are found to be eligible to take part in this study, you will begin receiving doxercalciferol. The dose you will receive will be based on how many participants have been enrolled before you, and on the safety data that is available. You will remain on the same dose level throughout this study. There will be up to 9 participants enrolled in each group of the same dose. The first group of participants enrolled on this study will be given small doses of doxercalciferol. If no intolerable side effects are experienced, the next group of participants will be enrolled at a higher dose level. This process will continue until researchers find the highest tolerable dose of doxercalciferol, among the 5 dose levels being tested, that can be given without intolerable side effects occurring.
Study Drug Administration:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written and voluntary consent obtained from the patient or their legal guardians.
- •Patient must be greater than 2 and less than 26 years old at time of study entry or at time of initial diagnosis
- •Patient must have had histologic verification of a solid malignancy at initial diagnosis (excluding brain stem tumors and visual pathway gliomas)
- •Patient must have recurrent measurable or evaluable disease after therapy or refractory to conventional therapy with presence of disease confirmed by standard imaging or biopsy
- •Must start protocol therapy within two weeks of disease evaluation and determination of eligibility.
- •Performance status of >20% on Lansky play scale for subjects <10 years of age, >20% on Karnofsky score for subjects >= 10 years of age
- •Patient must have fully recovered to less than or equal to grade 1 from the acute toxic effects of prior therapy, to meet eligibility criteria
- •Adequate bone marrow function defined as peripheral absolute neutrophil count (ANC) equal or more than 500/mm^3, Hemoglobin equal or more than 8g/dl, Platelets equal or more than 20,000/mm^3
- •Adequate renal function defined as serum creatinine <1.5 X upper limit of normal (ULN) or age adjusted creatinine clearance of >70ml/min/1.73m^2
- •Adequate liver function defined as total bilirubin <1.5 X upper limit of normal (ULN) and AST <2 X upper limit of normal (ULN)
- •Serum calcium, phosphorus, or PTH levels must be </= to the upper limit of normal age adjusted values per institutional guidelines.
- •Urine calcium level must be </= to the upper limit of normal value per institutional guidelines
- •Women of childbearing potential must have a negative serum or urine pregnancy test and not be breastfeeding prior to study therapy. Women of childbearing potential must be using an adequate form of contraception to avoid pregnancy during therapy and for at least 4 weeks after the end of study therapy in such a manner that the risk of pregnancy is minimized (Women of childbearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization)
排除标准
- •Any past history of urine calcium stones, idiopathic hypercalcemia, hereditary bone disease, or hypercalciuria in the subject
- •Concurrent Medications: Patients currently taking digitalis or thiazides are ineligible
- •Concurrent Medications: Oral calcium and vitamin D supplements and all homeopathic medications must be discontinued 2 weeks prior to study entry and while on study therapy.
- •Use of other anti-tumor therapy, including but not limited to chemotherapy, radiation therapy, immunotherapy, other investigational agents or other biologic therapy, during study therapy, with the exception of palliative radiation therapy to non-index lesions.
研究组 & 干预措施
Doxercalciferol
干预措施: Doxercalciferol (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD)
时间窗: Continual reassessment method during 28 day cycles, weekly visits for first cycle and monthly for each additional cycle
次要结局
未报告次要终点