Status:
COMPLETED
Phase 1 Study of Iobenguane (MIBG) I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma
Lead Sponsor:
Molecular Insight Pharmaceuticals, Inc.
Conditions:
Pheochromocytoma
Paraganglioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine whether iobenguane I 131 is safe and effective in patients with malignant pheochromocytoma or paraganglioma.
Detailed Description
This was originally designed as a phase 1/2 study. The phase 1 patients received a small dose of study drug to see if the tumors absorb the drug. If the patient's tumors absorbed the drug, then the pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00458952
Start Date
April 1 2007
End Date
June 1 2011
Last Update
July 13 2016
Active Locations (3)
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1
New York Presbyterian Hospital-Weill Cornell Medical Center
New York, New York, United States, 10021
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
3
Rhode Island Hospital
Providence, Rhode Island, United States, 02903