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N2007-01: Ultratrace™ Iobenguane I 131 in Patients With Relapsed/Refractory High-Risk Neuroblastoma

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ClinicalTrials.gov Identifier: NCT00659984
Recruitment Status : Completed
First Posted : April 17, 2008
Results First Posted : March 16, 2017
Last Update Posted : October 4, 2017
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
Condition: Neuroblastoma
Interventions: Drug: UltratraceTM Iobenguane I 131 Imaging
Drug: UltratraceTM Iobenguane I 131 Therapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ultratrace™ Iobenguane I 131

Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 within 7 days (d) of enrollment, followed by 3 dosimetry scans over 3-6 days. For the imaging dose, 0.1 mCi/kg (3.7 MBq/kg), at a min dose of 1 mCi (37 MBq) but not to exceed 5 mCi (185 MBq) of Ultratrace™ Iobenguane I 131 was administered 7-28 d prior to the therapeutic dose on Day 0. If the imaging dose demonstrated NL biodistribution/tumor uptake, pts received a therapeutic dose within 7-28 d of the imaging dose followed by a single imaging scan on Day 7 post therapy.

Therapeutic dosing was to begin at 12.0 mCi/kg and escalate to 15.0, 18.0, and 21.0 mCi/kg until the MTD was established or the 21.0 mCi/kg dose level was reached. Based on actual doses administered, pts were grouped into 3 mean dose groups: 11.2, 15.5, and 18.2 mCi/kg.

The dosimetry dose was administered over 1-3 mins by injection; the therapeutic dose was diluted in up to 25 mL normal saline and infused over 30 to 60 mins.


Participant Flow:   Overall Study
    Ultratrace™ Iobenguane I 131
STARTED   15 
COMPLETED   14 
NOT COMPLETED   1 
Adverse Event                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ultratrace™ Iobenguane I 131 Eligible patients received a diagnostic imaging dose of Ultratrace™ Iobenguane I 131 (1-5 mCi) within 7 days of study enrollment, followed by three dosimetry scans over 3-6 days. If the imaging dose demonstrated normal biodistribution and tumor uptake, then the patient received a therapeutic dose within 7-28 days of the diagnostic imaging dose, followed by a single imaging scan on Day 7 post therapy. Therapeutic dosing began at 12.0 mCi/kg and escalated to 15.0, 18.0, and 21.0 mCi/kg until the MTD was established or the 21.0 mCi/kg dose level was reached. The dosimetry dose was administered over a period of 1-3 minutes by injection; the therapeutic dose was diluted in up to 25 mL normal saline and infused intravenously over 30 to 60 minutes.

Baseline Measures
   Ultratrace™ Iobenguane I 131 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Years]
Median (Full Range)
 8 
 (3 to 30) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  40.0% 
Male      9  60.0% 
Region of Enrollment 
[Units: Participants]
 
United States   15 


  Outcome Measures

1.  Primary:   Maximum Tolerated Dose   [ Time Frame: Day 60 +/-10 or Engraftment, whichever comes first ]

2.  Secondary:   Dose Limiting Toxicities   [ Time Frame: From the time of signed informed consent until Day 60 or until the end of therapy evaluation is completed (whichever comes first). ]

3.  Secondary:   Dosimetric Estimation of Radiation Absorbed Doses to Measurable Lesions   [ Time Frame: Day 5 post Dosimetric Dose ]

4.  Secondary:   Overall Objective Tumor Response Post Therapeutic Treatment   [ Time Frame: Day 60 +/- 10 days post Therapeutic Dose ]

5.  Secondary:   Tumor Response in CT/MRI Lesions Post Therapeutic Treatment   [ Time Frame: Day 60 +/- 10 days post Therapeutic Dose ]

6.  Secondary:   Quality of Life   [ Time Frame: Day 60 +/- 10 days post Therapeutic Dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: NANT Operations Center
Organization: NANT Consortium
phone: 323-361-5687
e-mail: nantops@chla.usc.edu



Responsible Party: Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00659984     History of Changes
Other Study ID Numbers: CDR0000593357
NANT-2007-01 ( Other Identifier: NANT Consortium )
First Submitted: April 16, 2008
First Posted: April 17, 2008
Results First Submitted: December 15, 2015
Results First Posted: March 16, 2017
Last Update Posted: October 4, 2017