EUCTR2007-002211-11-GB进行中（未招募）不适用
A PHASE I-II STUDY EVALUATING THE MAXIMUM TOLERATED DOSE,DOSIMETRY, SAFETY, AND EFFICACY OF ULTRATRACE™ IOBENGUANE I 131 INPATIENTS WITH MALIGNANT PHEOCHROMOCYTOMA/PARAGANGLIOMA
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 62
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
- •Have a diagnosis of either adrenal pheochromocytoma or extra-adrenal paraganglioma by:
- •o histological confirmation –OR--
- •o plasma-free metanephrines and 24-hour urine test for catecholamines/metanephrines
- •Disease is metastatic or has recurred following surgery
- •At least one measurable lesion seen by computed tomography (CT) or magnetic resonance (MR) scan performed with IV contrast within 4 weeks prior to the first dose of study drug
- •At least one measurable tumor site is also seen on Ultratrace iobenguane I 131 scan
- •Provide written informed consent and are willing to comply with protocol requirements
- •Are at least 18 years of age
- •If female, then not of childbearing potential as documented by history (e.g., tubal ligation or hysterectomy) or is post menopausal with a minimum 1 year without menses
- •If female of childbearing potential, has a negative serum ßHCG pregnancy test within 48 hours prior to receiving iobenguane I 131
- •Females who agree not to become pregnant and males who agree not to father a child during the 1 year period following the therapeutic dose of Ultratrace iobenguane I 131. Both females and males must use an acceptable method of birth control during the first year following the therapeutic dose of Ultratrace iobenguane I 131.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Females who are nursing
- •Active CNS lesions by CT/MR scanning within 3 months of study entry
- •New York Heart Association class III-IV heart failure
- •Received any previous systemic radiotherapy within 6 months of study entry [prior carrier-added iobenguane I 131 therapy is allowed if not within 6 months]
- •Administered prior whole-body radiation therapy
- •Received external beam radiotherapy to > 25% of bone marrow
- •Administered prior chemotherapy within 30 days of study entry
- •Karnofsky performance status is < 60
- •Platelets = 100,000/µL
- •Absolute neutrophil count (ANC) = 1,500/µL
- •Serum creatinine = 1.5 mg/dL
- •Total bilirubin = 1.5 times the upper limit of normal
- •AST/SGOT or ALT/SGPT = 2.5 times the upper limit of normal
- •Has a known allergy to iobenguane, iodine, or SSKI that has required medical intervention
- •Has received a therapeutic investigational compound and/or medical device within 30 days before admission into this study
- •Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations
- •Has evidence of altered biodistribution of Ultratrace iobenguane I 131
- •Has evidence of renal obstruction
- •Is determined by the Investigator that the patient is clinically unsuitable for the study.
- •Has received a medication which inhibits uptake of iobenguane I 131:
- •- phenothiazines or decongestants within 2 weeks prior to the first dose of Ultratrace iobenguane
- •- a tricyclic antidepressant within 6 weeks prior to the first dose of Ultratrace iobenguane I 131;
- •- labetelol within 1 week prior to the first dose of Ultratrace iobenguane I 131.
研究者
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