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Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01041638
First Posted: January 1, 2010
Last Update Posted: April 13, 2016
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 3, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
Stage 4S Neuroblastoma
Interventions: Biological: Aldesleukin
Other: Diagnostic Laboratory Biomarker Analysis
Biological: Dinutuximab
Drug: Isotretinoin
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
Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin
STARTED   105 
COMPLETED   78 
NOT COMPLETED   27 
Adverse Event                4 
Death                1 
Lack of Efficacy                7 
Physician Decision                4 
Withdrawal by Subject                11 



  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
Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Baseline Measures
   Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin 
Overall Participants Analyzed 
[Units: Participants]
 		 105 
Age 
[Units: Years]
Median (Standard Deviation) 		 4.1  (4.0) 
Age 
[Units: Participants]
 		 
<=18 years   103 
Between 18 and 65 years   2 
>=65 years   0 
Gender 
[Units: Participants]
 		 
Female   46 
Male   59 
Race (NIH/OMB) 
[Units: Participants]
 		 
American Indian or Alaska Native   1 
Asian   2 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   10 
White   82 
More than one race   0 
Unknown or Not Reported   10 
Ethnicity (NIH/OMB) 
[Units: Participants]
 		 
Hispanic or Latino   9 
Not Hispanic or Latino   87 
Unknown or Not Reported   9 
Region of Enrollment 
[Units: Participants]
 		 
United States   105 


  Outcome Measures

1.  Primary:   Percentage of Patients Who Experienced a Significant (CTC Grade 3-5) Nonhematologic Toxicity of Interest (Pain, Hypotension, Allergic Reactions, Capillary Leak Syndrome, or Fever).   [ Time Frame: Up to 5 years ]
  Show Outcome Measure 1

2.  Secondary:   Event-free Survival   [ Time Frame: From enrollment until the first occurrence of relapse, progressive disease, secondary malignancy, or death, or until last contact if no event occurred, up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Overall Survival   [ Time Frame: From enrollment until death, or until last contact with the patient, up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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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
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  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



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01041638     History of Changes
Other Study ID Numbers: NCI-2011-01997
NCI-2011-01997 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ANBL0931
CDR0000662673
ANBL0931
ANBL0931 ( Other Identifier: Childrens Oncology Group )
ANBL0931 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: December 31, 2009
First Posted: January 1, 2010
Results First Submitted: February 3, 2015
Results First Posted: February 19, 2015
Last Update Posted: April 13, 2016



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