Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma
![]() |
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. |
ClinicalTrials.gov Identifier: NCT01041638 |
Recruitment Status :
Completed
First Posted : January 1, 2010
Results First Posted : February 19, 2015
Last Update Posted : August 17, 2021
|
Sponsor:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI)
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
High Risk Neuroblastoma |
Interventions |
Biological: Aldesleukin Other: Diagnostic Laboratory Biomarker Analysis Biological: Dinutuximab Drug: Isotretinoin Biological: Sargramostim |
Enrollment | 105 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | 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. |
Period Title: Overall Study | |
Started | 105 |
Completed | 78 |
Not Completed | 27 |
Reason Not Completed | |
Adverse Event | 4 |
Death | 1 |
Lack of Efficacy | 7 |
Physician Decision | 4 |
Withdrawal by Subject | 11 |
Baseline Characteristics
Arm/Group Title | 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. | |
Overall Number of Baseline Participants | 105 | |
![]() |
[Not Specified]
|
|
Age, Continuous
Median (Full Range) Unit of measure: Years |
||
Number Analyzed | 105 participants | |
4.1
(1.1 to 27.5)
|
||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 105 participants | |
<=18 years |
103 98.1%
|
|
Between 18 and 65 years |
2 1.9%
|
|
>=65 years |
0 0.0%
|
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 105 participants | |
Female |
46 43.8%
|
|
Male |
59 56.2%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 105 participants | |
American Indian or Alaska Native |
1 1.0%
|
|
Asian |
2 1.9%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
|
Black or African American |
10 9.5%
|
|
White |
82 78.1%
|
|
More than one race |
0 0.0%
|
|
Unknown or Not Reported |
10 9.5%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||
Number Analyzed | 105 participants | |
Hispanic or Latino |
9 8.6%
|
|
Not Hispanic or Latino |
87 82.9%
|
|
Unknown or Not Reported |
9 8.6%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||
United States | Number Analyzed | 105 participants |
105 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Results Reporting Coordinator |
Organization: | Children's Oncology Group |
Phone: | 626-447-0064 |
EMail: | resultsreportingcoordinator@childrensoncologygroup.org |
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT01041638 |
Other Study ID Numbers: |
NCI-2011-01997 NCI-2011-01997 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) COG-ANBL0931 ANBL0931 CDR0000662673 ANBL0931 ( Other Identifier: Children's 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: | August 17, 2021 |