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Trial record 13 of 526 for:    "Neuroblastoma"

Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma

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ClinicalTrials.gov Identifier: NCT00808899
Recruitment Status : Terminated (Voluntarily closed and terminated by the PI due to lack of feasibility)
First Posted : December 16, 2008
Results First Posted : May 20, 2010
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Neuroblastoma
Interventions: Drug: Temsirolimus
Drug: Irinotecan
Procedure: Surgical Resection of Primary Tumor
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Etoposide
Drug: Cisplatin
Drug: Topotecan
Procedure: PBSC
Radiation: Radiation Therapy
Drug: 13-cis-retinoic acid

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Four patients were recruited from December, 2008 through April, 2009. The study was suspended July, 2009 because of the publication of a new standard of care in treatment for patients with high-risk neuroblastoma.

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
Temsirolimus With Irinotecan Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.

Participant Flow:   Overall Study
    Temsirolimus With Irinotecan
STARTED   4 
COMPLETED   0 
NOT COMPLETED   4 
Death                1 
Physician Decision                3 



  Baseline Characteristics

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
Temsirolimus With Irinotecan Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.

Baseline Measures
   Temsirolimus With Irinotecan 
Overall Participants Analyzed 
[Units: Participants]
 4 
Age 
[Units: Years]
Mean (Standard Deviation)
 3.5  (1.21) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  50.0% 
Male      2  50.0% 


  Outcome Measures

1.  Primary:   Complete Response Plus Partial Response   [ Time Frame: 10 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
NB2008 was closed because of the publication of a new standard of care for treating high-risk neuroblastoma.At the time of closure, NB2008 had enrolled only 4 patients, which was an insufficient number of patients to answer the primary objective.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Wayne L. Furman
Organization: St. Jude Children's Research Hospital
phone: 1-866-278-5833
e-mail: info@stjude.org



Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00808899     History of Changes
Other Study ID Numbers: NB2008
First Submitted: December 11, 2008
First Posted: December 16, 2008
Results First Submitted: April 19, 2010
Results First Posted: May 20, 2010
Last Update Posted: May 30, 2017