Status:
UNKNOWN
A Study Evaluating Ultratrace Iobenguane I131 in Patients With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma
Lead Sponsor:
Molecular Insight Pharmaceuticals, Inc.
Conditions:
Pheochromocytoma
Paraganglioma
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
This clinical trial is designed to evaluate the effectiveness and collect additional safety information on AZEDRA® (iobenguane I 131) for the treatment of metastatic or relapsed/refractory (to other t...
Detailed Description
AZEDRA® (Iobenguane I 131) is a very high-specific-activity iobenguane I 131, produced using proprietary Ultratrace® platform. Based on the well-characterized cellular active transport mechanism, the ...
Eligibility Criteria
Inclusion
- Be at least 12 years of age
- Have a documented (medical record) diagnosis of either pheochromocytoma or paraganglioma
- Be ineligible for curative surgery for pheochromocytoma
- Have failed a prior therapy for pheochromocytoma/paraganglioma or are not candidates for chemotherapy or other curative therapies
- Be on stable antihypertensive medication for pheochromocytoma-related hypertension for at least 30 days
- Have at least one tumor site by CT or MR or iobenguane I 131 scan
- Have an expected survival of at least 6 months
- Subjects must agree to use an acceptable form of birth control (abstinence, IUD, oral contraception, barrier and spermicide or hormonal implant) during this study and for 6 months following Therapeutic Doses of Ultratrace Iobenguane I 131.
- Male subjects must agree not to father a child during the period beginning immediately after administration of the first Therapeutic Dose of Ultratrace Iobenguane I 131 during the study and ending six months after administration of the last Therapeutic Dose of Ultratrace Iobenguane I 131.
Exclusion
- Subjects will be excluded if any of the following conditions are observed:
- \<50% of FDG (if data are available) positive lesions are MIBG avid
- Pregnant or nursing females
- Active CNS lesions by CT/MR scanning within 3 months of study entry
- New York Heart Association class IV heart failure, symptomatic congestive heart failure \[New York Heart Association class IV with another medical disorder\], unstable angina pectoris, cardiac arrhythmia
- Received any previous systemic radiotherapy resulting in marrow toxicity within 3 months of study entry or have active malignancy (other than pheochromocytoma/paraganglioma) requiring additional treatment during the active phase or follow up period of the Ultratrace® iobenguane I 131 trial.
- Administered prior whole-body radiation therapy
- Received external beam radiotherapy to \> 25% of bone marrow
- Administered prior chemotherapy within 30 days or have active malignancy (other than pheochromocytoma/ paraganglioma) requiring additional treatment during the active phase or follow up period of the Ultratrace iobenguane I 131 trial.
- Karnofsky Performance Status is \< 60
- Platelets \< 80,000/μL
- Absolute neutrophil count (ANC) \< 1,200/μL, Total bilirubin \> 1.5 times the upper limit of normal, AST/SGOT or ALT/SGPT \> 2.5 times the upper limit of normal
- Diagnosed with AIDS or HIV-positive
- Active chronic alcohol abuse, chronic liver disease or hepatitis
- Renal dysfunction/impairment
- Known allergy to iobenguane that has required medical intervention
- Received a therapeutic investigational compound and/or medical device/prior chemotherapy within 30 days before admission into this study
- Receiving a medication which inhibits tumor uptake of iobenguane I 131
- Any medical condition or other circumstances (i.e., uncontrolled current illness including but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with the study requirements.
- Any other condition, that in the opinion of the investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study
Key Trial Info
Start Date :
June 4 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00874614
Start Date
June 4 2009
End Date
February 1 2021
Last Update
February 20 2020
Active Locations (10)
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1
University of California-San Francisco
San Francisco, California, United States, 94143
2
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
Johns Hopkins University
Baltimore, Maryland, United States, 21287