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Phase 1-2 Study of Iobenguane (MIBG) I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma

This study is currently recruiting participants.
Verified by Molecular Insight Pharmaceuticals, Inc., December 2007

Sponsored by: Molecular Insight Pharmaceuticals, Inc.
Information provided by: Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00458952
  Purpose

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


Condition Intervention Phase
Pheochromocytoma
Paraganglioma
Drug: Ultratrace Iobenguane (MIBG) I 131
Phase I
Phase II

MedlinePlus related topics:   Cancer    Pheochromocytoma   

Drug Information available for:   Iodine    Cadexomer iodine    Sodium iodide I 131    3-Iodobenzylguanidine    Iobenguane   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase I-II Study Evaluating the Maximum Tolerated Dose, Dosimetry, Safety, and Efficacy of Ultratrace Iobenguane I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma

Further study details as provided by Molecular Insight Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Phase1: toxicities (DLTs) in 1st 6 weeks after therapeutic (tx) dose [ Time Frame: 6 weeks post therapy dose ] [ Designated as safety issue: Yes ]
  • Phase2: tumor response by CT/MRI 9 months after tx dose [ Time Frame: 9 months after treatment dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase1: radiation absorbed 1 hour after dose 1(small dose), 2-4 days after dose 1, and 5-7 days after dose 1; tumor response by CT/MRI & blood/urine tests 3, 6, 9, & 12 months after tx dose; dose response by CT/MRI 9 months after tx dose [ Time Frame: post therapy ] [ Designated as safety issue: No ]
  • Phase2: tumor response by CT/MRI & blood/urine tests 3, 6, 9, & 12 month after tx dose; quality of life 3, 6, 9, & 12 months after tx dose [ Time Frame: post therapy ] [ Designated as safety issue: No ]

Estimated Enrollment:   49
Study Start Date:   April 2007
Estimated Study Completion Date:   April 2012

Intervention Details:
    Drug: Ultratrace Iobenguane (MIBG) I 131
    Phase I: Dose escalation protocol Phase II: Treatment schedule at therapeutic dose
Detailed Description:

This is a phase 1 and phase 2 study. The phase 1 patients will be enrolled before the phase 2 patients are enrolled. Each patient will receive a small dose to see if the tumors absorb the drug. If the patient's tumors absorb the drug, then the patient will receive one therapeutic dose. In the phase 1 portion, every 3 patients will be given the same therapeutic dose, and usually each group of 3 patients will be given a larger dose than people who were enrolled before them. Enrollment in the phase 1 portion will be complete once researches believe that they have found the highest dose that they can give patients without causing unacceptable toxicity. This dose is called the maximum tolerated dose (MTD). All phase 2 patients will receive the MTD. Each patient in phase 1 and phase 2 will be followed for 5 years following their therapeutic dose. During this 5-year follow-up period, patients will undergo tests such as 1.) CT or MRI scans and blood and urine tests to determine if the tumors shrink, grow, or stay the same; 2.) bone scans to see if the tumor has spread to or increased in the bones and, 3.) a quality of life test to see how the symptoms of pheochromocytoma or paraganglioma affect patients' daily lives.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458952

Locations
United States, Iowa
University of Iowa Medical Center     Not yet recruiting
      Iowa City, Iowa, United States, 52242
      Contact: Stacy Michael     319-335-8966     stacy-michael@uiowa.edu    
      Contact: Thomas O'Dorisio, M.D.     319-353-7812     thomas-odorisio@uiowa.edu    
      Principal Investigator: Thomas O'Dorisio, M.D.            
United States, Maryland
Johns Hopkins University     Not yet recruiting
      Baltimore, Maryland, United States, 21287-0817
      Contact: Yetty Olagbemiro         yolagbe1@jhmi.edu    
      Contact: Nicole Cooper         ncooper2@jhmi.edu    
      Principal Investigator: Richard L. Wahl, M.D.            
United States, Minnesota
Mayo Clinic     Not yet recruiting
      Rochester, Minnesota, United States, 55905
      Contact: Terry Brinkman     507-266-8330     brinkman.terry@mayo.edu    
      Contact: Gregory Wiseman     507-284-9599     gwiseman@mayo.edu    
      Principal Investigator: Gregory Wiseman, M.D.            
United States, Missouri
Mallinckrodt Institute of Radiology     Not yet recruiting
      St. Louis, Missouri, United States, 63110
      Contact: Jennifer Frye     314-747-1604     fryej@mir.wustl.edu    
      Contact: Perry W. Grigsby, M.D.     314-362-8502     pgrigsby@radonc.wustl.edu    
      Principal Investigator: Perry W. Grigsby, M.D.            
United States, New York
New York Presbyterian Hospital-Weill Cornell Medical Center     Recruiting
      New York, New York, United States, 10021
      Contact: Shankar Vallabhajosula, M.D.     212-746-5694     svallabh@med.cornell.edu    
      Contact: Zubaida Rahman, R.Ph.         zur9002@nyp.org    
      Principal Investigator: Stanley Goldsmith, M.D.            
Mount Sinai School of Medicine     Not yet recruiting
      New York, New York, United States, 10029
      Contact: Lale Kostakoglu, M.D.     212-241-6319     lale.kostakoglu@msnyuhealth.org    
      Principal Investigator: Lale Kostakoglu, M.D.            
United States, North Carolina
Duke University Medical Center     Recruiting
      Durham, North Carolina, United States, 27710
      Contact: Edward Coleman, M.D.     919-684-7244     colem010@mc.duke.edu    
      Contact: Beth Parente     919-970-1467     beth.parente@duke.edu    
      Principal Investigator: Edward Coleman, M.D.            
United States, Pennsylvania
Hospital of the University of Pennsylvania     Not yet recruiting
      Philadelphia, Pennsylvania, United States, 19104
      Contact: Alex Wills     215-662-3049     eze.wills@uphs.upenn.edu    
      Contact: Chaitanya Divgi, M.D.     215-615-3687     chaitanya.divgi@uphs.upenn.edu    
      Principal Investigator: Chaitanya Divgi, M.D.            
United States, Rhode Island
Rhode Island Hospital     Recruiting
      Providence, Rhode Island, United States, 02903
      Contact: Elizabeth Morrell     401-444-2277     emorrell@lifespan.org    
      Contact: Richard B. Noto, M.D.     401-444-5184     rnoto@lifespan.org    
      Principal Investigator: Richard B. Noto, M.D.            
Canada, Alberta
Cross Cancer Institute     Not yet recruiting
      Edmonton, Alberta, Canada, T6G 2N8
      Contact: Margaret Landon     780-432-8751     margland@cancerboard.ab.ca    
      Contact: Gail Amyotte     780-432-8202     gaila@cancerboard.ab.ca    
      Principal Investigator: Alexander J. McEwan, M.D.            
Canada, Ontario
London Health Sciences Centre     Not yet recruiting
      London, Ontario, Canada, N6A 5W9
      Contact: Patty Laverty     (519)685-8500 ext 76068     Patricia.Laverty@lhsc.on.ca    
      Contact: Susan Vandermark         Susan.Vandermark@lhsc.on.ca    
      Principal Investigator: Robert Reid, M.D.            

Sponsors and Collaborators
Molecular Insight Pharmaceuticals, Inc.

Investigators
Study Director:     Norman LaFrance, MD     Molecular Insight Pharmaceuticals    
  More Information


Responsible Party:   Molecular Insight Pharmaceuticals ( Jennifer Whalen )
Study ID Numbers:   MIP-IB12
First Received:   April 9, 2007
Last Updated:   December 8, 2007
ClinicalTrials.gov Identifier:   NCT00458952
Health Authority:   United States: Food and Drug Administration;   Canada: Health Canada

Keywords provided by Molecular Insight Pharmaceuticals, Inc.:
MIBG  
iobenguane  
iodine  
I 131  
radiotherapy  
radiopharmaceutical  
dosimetry
neuroendocrine tumor
Ultratrace
no carrier added
metaiodobenzyl-guanidine

Study placed in the following topic categories:
Neuroectodermal Tumors
Paraganglioma
3-Iodobenzylguanidine
Neoplasms, Germ Cell and Embryonal
Iodine
Neuroepithelioma
Pheochromocytoma
Neuroendocrine Tumors

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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