Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01041638
First received: December 31, 2009
Last updated: February 3, 2015
Last verified: November 2014
Results First Received: February 3, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Disseminated Neuroblastoma
Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Regional Neuroblastoma
Stage 4S Neuroblastoma
Interventions: Biological: aldesleukin
Biological: sargramostim
Biological: monoclonal antibody Ch14.18
Drug: isotretinoin

  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  
Number of Participants  
[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 ]

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.   Safety Issue:   No

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.   Safety Issue:   No


  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


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01041638     History of Changes
Other Study ID Numbers: NCI-2011-01997, NCI-2011-01997, COG-ANBL0931, CDR0000662673, ANBL0931, ANBL0931, U10CA098543
Study First Received: December 31, 2009
Results First Received: February 3, 2015
Last Updated: February 3, 2015
Health Authority: United States: Food and Drug Administration