Phase 1 Study of Iobenguane (MIBG) I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether iobenguane I 131 is safe and effective in patients with malignant pheochromocytoma or paraganglioma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Molecular Insight Pharmaceuticals, Inc.
• Treatments: 3-Iodobenzylguanidine

Criteria

Inclusion Criteria:

• Have a diagnosis of either adrenal pheochromocytoma or extra-adrenal paraganglioma by histological confirmation OR 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 within 4 weeks prior to the first dose of study drug

• At least one known 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 b-HCG 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.

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

• Administered prior whole-body radiation therapy

• Received external beam radiotherapy to greater than 25 percent of bone marrow

• Administered prior chemotherapy within 30 days of study entry

• Karnofsky performance status is less than 60

• Platelets are less than 100,000/uL

• Absolute neutrophil count (ANC) is less than 1,500/uL

• Serum creatinine is greater than 1.5 mg/dL

• Total bilirubin is greater than 1.5 times the upper limit of normal

• AST/SGOT or ALT/SGPT is greater than 2.5 times the upper limit of normal

• 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

• 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 enrollment; or,

• a tricyclic antidepressant within 6 weeks prior to enrollment.