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Trial record 10 of 77 for:    "Carotid body tumor"

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

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ClinicalTrials.gov Identifier: NCT00458952
Recruitment Status : Completed
First Posted : April 11, 2007
Results First Posted : April 20, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
Molecular Insight Pharmaceuticals, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pheochromocytoma
Paraganglioma
Intervention Drug: Ultratrace Iobenguane (MIBG) I 131
Enrollment 24
Recruitment Details 24 patients with confirmed pheochromocytoma/paraganglioma were recruited for participation in the trial at 3 US sites. 21 patients received Ultratrace Iobenguane I 131 while 3 patients failed to meet all inclusion/exclusion criteria and were therefore not dosed.
Pre-assignment Details Planned Doses: 6, 7, 8 & 9 mCi/kg. Dose reductions in 7, 8 & 9 mCi/kg cohorts were made so total activity administered to pts would not greatly exceed allowed total activity of 525, 600, & 675 mCi for these groups, respectively. Thus, pts were subsequently analyzed in 2 groups of ≤500 mCi and >500mCi, consisting of 7 & 14 patients, respectively.
Arm/Group Title =< 500 mCi Ultratrace Iobenguane I 131 >500 mCi
Hide Arm/Group Description 7 subjects received a mean dose less than or equal to 500 mCi of Ultratrace Iobenguane I 131 14 subjects received a mean dose of greater than 500 mCi of Ultratrace Iobenguane I 131
Period Title: Overall Study
Started 7 14
Completed 5 9
Not Completed 2 5
Arm/Group Title =< 500 mCi Ultratrace Iobenguane I 131 >500 mCi Total
Hide Arm/Group Description 7 subjects received a mean dose less than or equal to 500 mCi of Ultratrace Iobenguane I 131 14 subjects received a mean dose of greater than 500 mCi of Ultratrace Iobenguane I 131 Total of all reporting groups
Overall Number of Baseline Participants 7 14 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 14 participants 21 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  85.7%
12
  85.7%
18
  85.7%
>=65 years
1
  14.3%
2
  14.3%
3
  14.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 14 participants 21 participants
46.4  (15.99) 52.4  (11.41) 50.4  (13.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 14 participants 21 participants
Female
2
  28.6%
3
  21.4%
5
  23.8%
Male
5
  71.4%
11
  78.6%
16
  76.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 14 participants 21 participants
7 14 21
1.Primary Outcome
Title MTD of Ultratrace Iobenguane I 131
Hide Description 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.
Time Frame 6 weeks post therapy dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
24 patients with confirmed pheochromocytoma/paraganglioma were recruited for participation in this trial. Of the 24 consenting patients, 21 patients were administered Ultratrace iobenguane I 131. Three patients did not meet all the inclusion and exclusion criteria, and were not allowed into the study.
Arm/Group Title Ultratrace Iobenguane I 131
Hide Arm/Group Description:
Each patient was to first receive an imaging dose of 5 mCi of Ultratrace iobenguane I 131 to confirm tumor uptake of the test article. If at least one tumor on a baseline CT/MRI scan was also visualized on the Ultratrace iobenguane I 131 scan, the patient was administered a therapeutic dose of Ultratrace iobenguane I 131. Dosing began at 6 mCi/kg for an initial cohort of 3 patients, and escalated in 1.0 mCi/kg increments until the MTD was established.
Overall Number of Participants Analyzed 21
Measure Type: Number
Unit of Measure: mCi/kg
8
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ultratrace Iobenguane I 131
Hide Arm/Group Description Each patient was to first receive an imaging dose of 5 mCi of Ultratrace iobenguane I 131 to confirm tumor uptake of the test article. If at least one tumor on a baseline CT/MRI scan was also visualized on the Ultratrace iobenguane I 131 scan, the patient was administered a therapeutic dose of Ultratrace iobenguane I 131. Dosing began at 6 mCi/kg for an initial cohort of 3 patients, and escalated in 1.0 mCi/kg increments until the MTD was established.
All-Cause Mortality
Ultratrace Iobenguane I 131
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ultratrace Iobenguane I 131
Affected / at Risk (%) # Events
Total   15/21 (71.43%)    
Blood and lymphatic system disorders   
Neutropenia  1/21 (4.76%) 
Pancytopenia  1/21 (4.76%) 
Gastrointestinal disorders   
Ileus  1/21 (4.76%) 
Gastrointestinal obstruction  1/21 (4.76%) 
General disorders   
Chest pain  1/21 (4.76%) 
Non-cardiac chest pain  1/21 (4.76%) 
Investigations   
Platelet count decreased  1/21 (4.76%)  2
Metabolism and nutrition disorders   
Dehydration  2/21 (9.52%) 
Musculoskeletal and connective tissue disorders   
Muscular weakness  1/21 (4.76%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bladder cancer  1/21 (4.76%) 
Metastasis  3/21 (14.29%) 
Nervous system disorders   
Spinal disorder  1/21 (4.76%) 
Thalamic infarction  1/21 (4.76%) 
Vascular disorders   
Deep vein thrombosis  1/21 (4.76%) 
Pulmonary embolism  1/21 (4.76%) 
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ultratrace Iobenguane I 131
Affected / at Risk (%) # Events
Total   20/21 (95.24%)    
Blood and lymphatic system disorders   
Leukopenia  10/21 (47.62%) 
Neutropenia  9/21 (42.86%) 
Thrombocytopenia  10/21 (47.62%) 
Anemia  9/21 (42.86%) 
General disorders   
Fatigue  14/21 (66.67%) 
Asthenia  4/21 (19.05%) 
Injection site irritation  3/21 (14.29%) 
Edema peripheral  3/21 (14.29%) 
Pyrexia  3/21 (14.29%) 
Investigations   
Platelet count decreased  8/21 (38.10%) 
White blood cell count decreased  6/21 (28.57%) 
Neutrophil  5/21 (23.81%) 
Blood thyroid stimulating hormone decreased  4/21 (19.05%) 
Hemoglobin decreased  4/21 (19.05%) 
Blood glucose increased  3/21 (14.29%) 
Hematocrit decreased  3/21 (14.29%) 
Metabolism and nutrition disorders   
Anorexia  8/21 (38.10%) 
Dehydration  1/21 (4.76%) 
Musculoskeletal and connective tissue disorders   
Back pain  5/21 (23.81%) 
Pain in extremity  4/21 (19.05%) 
Pain in jaw  3/21 (14.29%) 
Nervous system disorders   
Headache  6/21 (28.57%) 
Ageusia  5/21 (23.81%) 
Dizziness  3/21 (14.29%) 
Respiratory, thoracic and mediastinal disorders   
Cough  5/21 (23.81%) 
Epistaxis  4/21 (19.05%) 
Skin and subcutaneous tissue disorders   
Alopecia  5/21 (23.81%) 
Vascular disorders   
Hypotension  3/21 (14.29%) 
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Senior Director, Clinical Science Communications
Organization: Progenics Pharmaceuticals, Inc.
Phone: 914 784-1825
Responsible Party: Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00458952     History of Changes
Other Study ID Numbers: MIP-IB12
First Submitted: April 9, 2007
First Posted: April 11, 2007
Results First Submitted: December 15, 2015
Results First Posted: April 20, 2016
Last Update Posted: July 13, 2016