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Busulfan, Melphalan, and Stem Cell Transplant After Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma

This study has suspended participant recruitment.
(CRM: 31684 - CTEP PIO requested)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01798004
First received: January 6, 2013
Last updated: February 9, 2017
Last verified: November 2016
Results First Received: December 19, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Disseminated Neuroblastoma
Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Regional Neuroblastoma
Stage 4S Neuroblastoma
Interventions: Drug: cyclophosphamide
Drug: topotecan hydrochloride
Drug: cisplatin
Drug: etoposide
Drug: vincristine sulfate
Drug: doxorubicin hydrochloride
Radiation: external beam radiation therapy
Drug: busulfan
Drug: melphalan
Procedure: autologous hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Other: pharmacological study
Other: laboratory biomarker analysis
Biological: filgrastim
Drug: mesna

  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
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Reporting Groups
  Description
All Patients Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT

Participant Flow:   Overall Study
    All Patients
STARTED   150 
COMPLETED   63 
NOT COMPLETED   87 
Death                2 
Lack of Efficacy                8 
Physician Decision                25 
Withdrawal by Subject                4 
Ineligible                4 
Patient/parent refusal                7 
Initiation of other non-protocol therapy                5 
Enrollment another COG therapeutic trial                32 



  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
All Patients Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT

Baseline Measures
   All Patients 
Overall Participants Analyzed 
[Units: Participants]
 150 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      149  99.3% 
Between 18 and 65 years      1   0.7% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Median (Full Range)
 3.1 
 (0.4 to 18.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      60  40.0% 
Male      90  60.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      19  12.7% 
Not Hispanic or Latino      129  86.0% 
Unknown or Not Reported      2   1.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      11   7.3% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      21  14.0% 
White      107  71.3% 
More than one race      0   0.0% 
Unknown or Not Reported      11   7.3% 
Region of Enrollment 
[Units: Participants]
 
New Zealand   1 
Canada   14 
United States   132 
Australia   3 


  Outcome Measures

1.  Primary:   The Tolerability of BuMel Regimen   [ Time Frame: Up to 28 days post-consolidation therapy, up to 1 year ]

2.  Other Pre-specified:   Incidence of Non-hematologic Organ Toxicity (Grade 3 and Higher) and All Cause Mortality Graded According to CTC v4.0   [ Time Frame: Up to 180 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Other Pre-specified:   Response Rate Determined Using the International Response Criteria   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Other Pre-specified:   EFS   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Other Pre-specified:   Overall Survival   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Other Pre-specified:   First Dose Area Under the Curve (AUC) and Average Daily AUC for Busulfan   [ Time Frame: Within 28 days following consolidation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   Percentage of Centrally Reviewed Post-course 4 MIBG Scans Reporting a Curie Score Considered to Have Been Determined in “Real Time”   [ Time Frame: Up to week 12 (course 4 of induction therapy) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Other Pre-specified:   Percentage of MIBG Scans Receiving Institutionally and Centrally Reviewed and Automated Advanced Assisted Scoring Platform Curie Scores Within 1 Unit of Each Other   [ Time Frame: Up to week 12 (course 4 of induction therapy) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Other Pre-specified:   Proportion of High-risk Neuroblastoma Patients for Whom ALK Status Can be Obtained   [ Time Frame: Within 6 weeks of diagnosis ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Other Pre-specified:   Proportion of High-risk Neuroblastoma Patients With MYCN Non-amplified Tumors for Whom Molecular Profiling Results Can be Obtained   [ Time Frame: Within 8 weeks of diagnosis ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Other Pre-specified:   Melphalan Pharmacokinetics and the Combination of Busulfan and Melphalan AUC (Optional)   [ Time Frame: Within 28 days post-consolidation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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: NCT01798004     History of Changes
Other Study ID Numbers: ANBL12P1
NCI-2012-02211 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ANBL12P1
ANBL12P1 ( Other Identifier: Children's Oncology Group )
ANBL12P1 ( Other Identifier: CTEP )
U10CA098543 ( US NIH Grant/Contract Award Number )
U10CA180886 ( US NIH Grant/Contract Award Number )
Study First Received: January 6, 2013
Results First Received: December 19, 2016
Last Updated: February 9, 2017