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Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01175356
First Posted: August 4, 2010
Last Update Posted: September 28, 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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
Results First Submitted: July 26, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Disseminated Neuroblastoma
Ganglioneuroblastoma
Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Regional Neuroblastoma
Stage 4S Neuroblastoma
Interventions: Drug: cyclophosphamide
Drug: topotecan hydrochloride
Drug: cisplatin
Drug: etoposide phosphate
Drug: vincristine sulfate
Drug: doxorubicin hydrochloride
Radiation: iobenguane I 131
Procedure: therapeutic conventional surgery
Drug: busulfan
Drug: melphalan
Procedure: autologous hematopoietic stem cell transplantation
Procedure: in vitro-treated peripheral blood stem cell transplantation
Radiation: 3-dimensional conformal radiation therapy
Radiation: external beam radiation therapy
Radiation: intensity-modulated radiation therapy
Drug: isotretinoin
Other: pharmacological study
Other: questionnaire administration
Other: laboratory biomarker analysis

  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
Treatment (131I-MIBG, Chemotherapy) Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.

Participant Flow:   Overall Study
    Treatment (131I-MIBG, Chemotherapy)
STARTED   99 
COMPLETED   18 
NOT COMPLETED   81 
Death                1 
Lack of Efficacy                12 
Lost to Follow-up                1 
Physician Decision                23 
Ineligible                1 
Treatment Slot Not Available                18 
Refusal by patient/parent/guardian                6 
Pts MIBG non-avid after enrollment                2 
On other COG study w/tumor tx intent                7 
Inadequate stem cell for transplant                1 
Initiation other tx prior to completion                9 



  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
Treatment (131I-MIBG, Chemotherapy) Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.

Baseline Measures
   Treatment (131I-MIBG, Chemotherapy) 
Overall Participants Analyzed 
[Units: Participants]
 99 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      99 100.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 4.2  (2.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      39  39.4% 
Male      60  60.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      6   6.1% 
Not Hispanic or Latino      86  86.9% 
Unknown or Not Reported      7   7.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      1   1.0% 
Asian      3   3.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      18  18.2% 
White      64  64.6% 
More than one race      0   0.0% 
Unknown or Not Reported      13  13.1% 


  Outcome Measures
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1.  Primary:   Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131   [ Time Frame: Up to 6 weeks after course 5 of induction ]

2.  Primary:   Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy   [ Time Frame: Up to day -6 of conditioning ]

3.  Secondary:   Incidence of Unacceptable Toxicity and Sinusoidal Obstruction Syndrome (SOS), Assessed by Common Terminology Criteria (CTV)v.4.0 for Toxicity Assessment and Grading for I-MIBG   [ Time Frame: Up to 6 weeks after course 5 of induction ]


  Serious Adverse Events


  Other Adverse Events


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01175356     History of Changes
Other Study ID Numbers: ANBL09P1
NCI-2011-01745 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000682629 ( Other Identifier: ClinicalTrials.gov )
ANBL09P1 ( Other Identifier: Children's Oncology Group )
ANBL09P1 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: August 3, 2010
First Posted: August 4, 2010
Results First Submitted: July 26, 2017
Results First Posted: September 28, 2017
Last Update Posted: September 28, 2017