MALIGNANT PHEOCHROMOCYTOMA/PARAGANGLIOMA MedDRA version: 9.1 Level: LLT Classification code 10034876 Term: Pheochromocytoma
Conditions
Interventions
Product Name: Azedra™ Ultratrace™ Iobenguane I 131
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Iobenguane I 131
CAS Number: 80663-95-2
Other descriptive name: Ultratrace™
Concentrat
Sponsors
Molecular Insight Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I • To determine the maximum tolerated dose (MTD) of Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma Phase II • To determine the objective tumor response rate and its 95% confidence interval at 9 months following treatment with Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma;Secondary Objective: Phase I • Estimate radiation absorbed doses to target lesions and to a standard set of normal organs following a 5.0 mCi tracer infusion of Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma • Assess objective tumor response at 3, 6, 9 & 12 months following treatment with Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma Phase II • Assess the objective tumor response rate and its 95% confidence interval at 3, 6, and 12 months following treatment with Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma • Determine the biochemical response rate and its 95% confidence interval at 3, 6, 9, and 12 months following treatment with Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma Only the first two secondary objectives are listed for each phase of the study. For the full list please refer to the protocol. ;Primary end point(s): Dosimetry [phase I only] - radiation absorbed doses to target lesions and to normal organs in accordance with MIRD Efficacy: - objective tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) - dose-response [phase I only] - biochemical response Safety: - maximum tolerated dose [phase I only] - treatment emergent AEs - clinical laboratory measurements - vital signs measurements - ECG measurements - physical examination findings | — |
Countries
United Kingdom
Outcome results
None listed