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Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00026312
First Posted: January 27, 2003
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: February 9, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Recurrent Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
Stage 4S Neuroblastoma
Interventions: Biological: Aldesleukin
Biological: Dinutuximab
Drug: Isotretinoin
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Other: Quality-of-Life Assessment
Biological: Sargramostim

  Participant Flow
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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
Regimen A Randomized to Regimen A – RA Only
Regimen B Regimen B – RA + Immunotherapy

Participant Flow:   Overall Study
    Regimen A   Regimen B
STARTED   116   1333 
COMPLETED   82   1064 
NOT COMPLETED   34   269 
Adverse Event                0                32 
Death                1                7 
Lack of Efficacy                19                114 
Lost to Follow-up                0                5 
Physician Decision                1                37 
Protocol Violation                0                3 
Withdrawal by Subject                1                6 
Ineligible                4                5 
Entry onto another COG study                0                1 
Refusal by patient/parent/guardian                8                59 



  Baseline Characteristics
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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
Regimen A Randomized to Regimen A - RA Only
Regimen B Regimen B - RA + Immunotherapy
Total Total of all reporting groups

Baseline Measures
   Regimen A   Regimen B   Total 
Overall Participants Analyzed 
[Units: Participants]
 116   1333   1449 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      116 100.0%      1325  99.4%      1441  99.4% 
Between 18 and 65 years      0   0.0%      8   0.6%      8   0.6% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 3.22  (2.12)   3.64  (2.77)   3.61  (2.73) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      49  42.2%      534  40.1%      583  40.2% 
Male      67  57.8%      799  59.9%      866  59.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      11   9.5%      142  10.7%      153  10.6% 
Not Hispanic or Latino      99  85.3%      1159  86.9%      1258  86.8% 
Unknown or Not Reported      6   5.2%      32   2.4%      38   2.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      3   0.2%      3   0.2% 
Asian      4   3.4%      62   4.7%      66   4.6% 
Native Hawaiian or Other Pacific Islander      2   1.7%      2   0.2%      4   0.3% 
Black or African American      8   6.9%      153  11.5%      161  11.1% 
White      89  76.7%      942  70.7%      1031  71.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      13  11.2%      171  12.8%      184  12.7% 
Region of Enrollment 
[Units: Participants]
     
New Zealand   0   17   17 
Canada   13   135   148 
United States   100   1092   1192 
Australia   3   89   92 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Event-Free Survival (EFS)   [ Time Frame: Three years ]

2.  Secondary:   Event-Free Survival (EFS)   [ Time Frame: Three years ]

3.  Secondary:   Event-Free Survival (EFS) of Patients From the Non-randomized Portion of the Trial   [ Time Frame: Three years ]

4.  Secondary:   Incidence of Toxicities Assessed Using Common Terminology Criteria for Adverse Events Version 4.0   [ Time Frame: From enrollment to follow-up ]

5.  Secondary:   Number of Courses of Therapy Delivered   [ Time Frame: Courses 1-6 ]

6.  Secondary:   Overall Survival (OS)   [ Time Frame: Three years ]

7.  Secondary:   Overall Survival (OS) of Patients From the Non-randomized Portion of the Trial   [ Time Frame: Three years ]

8.  Other Pre-specified:   Average Level of HACA   [ Time Frame: Up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Other Pre-specified:   Cardiac Repolarization   [ Time Frame: Up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Other Pre-specified:   Change in MRD   [ Time Frame: Baseline to up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Other Pre-specified:   Change in Tumor Biology   [ Time Frame: Baseline to up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Other Pre-specified:   Circulating B7-H6 Levels   [ Time Frame: 1 week before first sargramostim injection (day -1 of course 1) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

13.  Other Pre-specified:   Genotype of FcR   [ Time Frame: Up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

14.  Other Pre-specified:   Genotype of Kir/Kir-ligand   [ Time Frame: Up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

15.  Other Pre-specified:   Isotretinoin Pharmacokinetic Parameters   [ Time Frame: At 4 hours after administration on day 14 of course 1 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

16.  Other Pre-specified:   Levels of ADCC   [ Time Frame: Up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

17.  Other Pre-specified:   NKp30 Isoform Expression and SNP   [ Time Frame: 1 week before first sargramostim injection (day -1 of course 1) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

18.  Other Pre-specified:   Presence of Naturally Occurring Anti-glycan Antibodies   [ Time Frame: Up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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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: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00026312     History of Changes
Other Study ID Numbers: NCI-2009-01064
NCI-2009-01064 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000069018
COG-ANBL0032
PANBL0032_A33PAMDREVW01
ANBL0032
ANBL0032 ( Other Identifier: Childrens Oncology Group )
ANBL0032 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA030969 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: November 9, 2001
First Posted: January 27, 2003
Results First Submitted: February 9, 2017
Results First Posted: March 29, 2017
Last Update Posted: May 10, 2017