EUCTR2011-004934-32-Outside-EU/EEA进行中（未招募）不适用
A phase I/II trial of vandetanib in children and adolescents with hereditary medullary thyroid cancer.
ational Cancer Institute0 个研究点目标入组 21 人开始时间: 2012年3月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 21
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
- All
入选标准
- •Participants must be 5 to 18 years of age, inclusive.
- •Diagnosis: Hereditary (MEN 2A or MEN 2B) medullary thyroid carcinoma (histologically confirmed) that is unresectable, recurrent or metastatic. Participants must have previously had a characteristic germline mutation in the RET proto-oncogene documented. Results of the germline mutation testing will be obtained from the referring institution.
- •Participants must have measurable disease as defined in RECIST as the presence of at least one lesion that can be accurately measured in at least one dimension with longest diameter of at least 20 mm using conventional techniques or at least 10 mm with spiral CT scan. Superficial (easily palpable) lymph nodes will be considered measurable.
- •Participants must be able to take one of the oral formulations of vandetanib.
- •Prior therapy: There are no standard chemotherapy regimens known to be effective for MTC. Therefore, previously untreated partipants are eligible if their tumor(s) are not surgically resectable.
- •Participants must be at least 4 weeks from prior surgical procedures and surgical incisions must be healed.
- •Participants must have had their last fraction of external beam radiation therapy at least 4 weeks prior to enrollment.
- •Participants must have had their last dose of cytotoxic chemotherapy at least 28 days prior to enrollment, their last dose of biological therapy, such as biological response modifiers (e.g., cytokines), immunomodulatory agents, vaccines, differentiating agents, used to treat their cancer at least 7 days prior to enrollment, their last dose of a monoclonal antibody at least 30 days prior to enrollment, and their last dose of any investigational agent at least 30 days prior to enrollment.
- •Participants must have received their last dose of short acting colony stimulating factor, such as filgrastim or sargramostim at least 72 hours prior to enrollment and their last dose of long-acting colony stimulating factors, such as PEG-filgrastim at least 7 days prior to enrollment.
- •Participants must have recovered from the acute toxic effects of prior therapy to a grade 1 (CTCAE v.3.0) level prior to enrollment.
- •Performance Status: Lansky (for participants 10 years of age or younger) or Karnofsky (for participants older than 10 years) performance score greater than 50
- •Participants who have previously had a thyroidectomy should be on thyroid hormone replacement therapy.
- •The peripheral absolute neutrophil count must be at least 1500 micro liters and the platelet count must be at least 1000 micro liters within 72 hours prior to enrollment.
- •PT and PTT must not be more than 1.5 x ULN within 72 hours prior to enrollment. PT and PTT should drawn by venipuncture, rather than from a central venous catheter when feasible.
- •Bilirubin must not be more than 1.5 x ULN and the AST and ALT must not be more than 2.5 x ULN within 72 hours prior to enrollment. AST and ALT may be up to 5 x ULN within 72 hours prior to enrollment in participants with hepatic metastases.
- •Participants must have an age-adjusted normal serum creatinine or a creatinine clearance of at least 60 ml/min/1.73 m2.
- •Participants of child-bearing or child-fathering potential must be willing to use a medically effective form of birth control, which includes abstinence, while taking vandetanib and for 2 months after the last dose.
- •Negative pregnancy test for women of c
排除标准
- •Pregnant or breast feeding females because the anti-angiogenic properties of vandetanib may be harmful to the developing fetus or nursing infant.
- •Participants with pheochromocytoma as evidenced by elevated plasma free metanephrines.
- •Participants with a serum potassium less than 3.5 mmol/L or a serum calcium or magnesium below the lower limits of normal. Correction of these electrolyte abnormalities with supplements is allowed.
- •Participants with a history of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, uncontrolled atrial fibrillation, left bundle branch block) that is symptomatic or requires treatment (except for controlled atrial fibrillation)
- •Participants with a history of congenitally prolonged QTc, a first degree relative with unexplained sudden death under 40 years of age, or a measured QTc (Bazett's correction) longer than 480 msec on ECG. ECGs should be performed after correction of electrolyte abnormalities. Participants with a prolonged QTc should have a repeat ECG at least 24 hour after the first, and the mean of the 2 QTcs should not exceed 480 msec.
- •Participants who experienced QTc prolongation with other medications requiring discontinuation of that medication.
- •Participants receiving a medication that has a known risk of QTc prolongation within 14 days (28 days for levomethadyl) of enrollment.
- •Diastolic blood pressure above the 95% for age on at least 2 of 3 measurements with an appropriate-size cuff or patients who are currently taking anti-hypertensive therapy.
- •Other clinically severe or uncontrolled systemic illness that could compromise the participants ability to tolerate vandetanib or could compromise study procedures or endpoints.
研究者
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