- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00458952
Phase 1 Study of Iobenguane (MIBG) I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma
June 13, 2016 updated by: Molecular Insight Pharmaceuticals, Inc.
A Phase I Study Evaluating the Maximum Tolerated Dose, Dosimetry, Safety, and Efficacy of Ultratrace Iobenguane I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma
The purpose of this study is to determine whether iobenguane I 131 is safe and effective in patients with malignant pheochromocytoma or paraganglioma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 patient received one therapeutic dose.
In the phase 1 portion, the study employed a 3 + 3 dose escalation design.
Enrollment in the phase 1 portion was to be completed once researches believed that they found the highest dose that they could give patients without causing unacceptable toxicity.
This dose is called the maximum tolerated dose (MTD).
Following discussions with the Food and Drug Administration (FDA) that occurred during the dose escalation stage of the study, the protocol was amended to conclude the trial upon the identification of the MTD.
The Phase 2 safety/ efficacy stage of the study was conducted with modifications of the primary endpoint as Protocol MIP IB12B, with Special Protocol Assessment Agreement with the FDA in March 2009.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10021
- New York Presbyterian Hospital-Weill Cornell Medical Center
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose Escalation
Dosing of Ultratrace iobenguane I 131 began at 6.0 mCi/kg and escalated in 1.0 mCi/kg increments in order to establish the MTD.
The MTD is the dose immediately below the level at which escalation stops due to dose-limiting toxicity (DLT).
An additional 3 patients are to be treated at the MTD, for a total of 6.
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Phase I: Dose escalation protocol Phase II: Treatment schedule at therapeutic dose
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MTD of Ultratrace Iobenguane I 131
Time Frame: 6 weeks post therapy dose
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Although no primary efficacy endpoint was defined for this study, the MTD of Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma (a safety rather than an efficacy parameter) is the primary objective.
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6 weeks post therapy dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Molecular Insight Pharmaceuticals, MIP
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
April 9, 2007
First Submitted That Met QC Criteria
April 9, 2007
First Posted (Estimate)
April 11, 2007
Study Record Updates
Last Update Posted (Estimate)
July 13, 2016
Last Update Submitted That Met QC Criteria
June 13, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Pheochromocytoma
- Paraganglioma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Radiopharmaceuticals
- 3-Iodobenzylguanidine
Other Study ID Numbers
- MIP-IB12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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