A PHASE I-II STUDY EVALUATING THE MAXIMUM TOLERATED DOSE,DOSIMETRY, SAFETY, AND EFFICACY OF ULTRATRACE™ IOBENGUANE I 131 INPATIENTS WITH MALIGNANT PHEOCHROMOCYTOMA/PARAGANGLIOMA
- Conditions
- MALIGNANT PHEOCHROMOCYTOMA/PARAGANGLIOMAMedDRA version: 9.1Level: LLTClassification code 10034876Term: Pheochromocytoma
- Registration Number
- EUCTR2007-002211-11-GB
- Lead Sponsor
- Molecular Insight Pharmaceuticals, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 62
• 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
• 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
I 131;
- a tricyclic antidepressant within 6 weeks prior to the first dose of Ultratrace iobenguane I 131;
or,
- labetelol within 1 week prior to the first dose of Ultratrace iobenguane I 131.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method