Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 87 of 163 for:    ISOTRETINOIN

3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Primary Refractory Neuroblastoma in Bone Marrow

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: NCT01183897
Recruitment Status : Completed
First Posted : August 18, 2010
Results First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neuroblastoma
Intervention Biological: 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic
Hide Arm/Group Description This phase II study of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response in of primary refractory neuroblastoma in bone marrow (i.e., incomplete response to standard treatment).
Period Title: Overall Study
Started 31
Completed 31
Not Completed 0
Arm/Group Title 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic
Hide Arm/Group Description This phase II study of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response in of primary refractory neuroblastoma in bone marrow (i.e., incomplete response to standard treatment).
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
<=18 years
31
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
9
  29.0%
Male
22
  71.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
31
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   3.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   3.2%
White
27
  87.1%
More than one race
0
   0.0%
Unknown or Not Reported
2
   6.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants
United States 28
Greece 1
Israel 2
1.Primary Outcome
Title Assess the Activity of High-dose 3F8/GM-CSF
Hide Description against persistent neuroblastoma in bone marrow of patients who have no other evidence of disease by standard studies.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic
Hide Arm/Group Description:
This phase II study of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response in of primary refractory neuroblastoma in bone marrow (i.e., incomplete response to standard treatment).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Apply Real-time Quantitative RT-PCR
Hide Description to test the hypothesis that the minimal residual disease content of bone marrow after the first treatments with 3F8/GMCSF has significant prognostic impact on progression-free survival.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic
Hide Arm/Group Description:
This phase II study of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response in of primary refractory neuroblastoma in bone marrow (i.e., incomplete response to standard treatment).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Monitor Safety of the High-dose Antibody Treatment
Hide Description to assure no side-effects or noxious sequelae develop or emerge that were not seen in the prior phase I study.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic
Hide Arm/Group Description:
This phase II study of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response in of primary refractory neuroblastoma in bone marrow (i.e., incomplete response to standard treatment).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description Data were not collected
 
Arm/Group Title 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic
Hide Arm/Group Description This phase II study of the anti-GD2 murine IgG3 monoclonal antibody 3F8 combined with granulocyte-macrophage colony stimulating factor (GM-CSF) will assess response in of primary refractory neuroblastoma in bone marrow (i.e., incomplete response to standard treatment).
All-Cause Mortality
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic
Affected / at Risk (%)
Total   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Brian Kushner MD
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-6793
EMail: kushnerb@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01183897     History of Changes
Other Study ID Numbers: 09-161
First Submitted: August 16, 2010
First Posted: August 18, 2010
Results First Submitted: July 24, 2019
Results First Posted: August 13, 2019
Last Update Posted: August 13, 2019