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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
Enrollment 4
Recruitment Details 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  
Arm/Group Title Temsirolimus With Irinotecan
Hide Arm/Group Description Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
Period Title: Overall Study
Started 4
Completed 0
Not Completed 4
Reason Not Completed
Death             1
Physician Decision             3
Arm/Group Title Temsirolimus With Irinotecan
Hide Arm/Group Description Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
3.5  (1.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
1.Primary Outcome
Title Complete Response Plus Partial Response
Hide Description The objective was to measure the efficacy and feasability of Temsirolimus and Irinotecan as measured by the objective response rate and toxicity rate.
Time Frame 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population consisted of patients eligible for enrollment onto the NB2008 protocol.
Arm/Group Title Temsirolimus With Irinotecan
Hide Arm/Group Description:
Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 10 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Temsirolimus With Irinotecan
Hide Arm/Group Description Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
All-Cause Mortality
Temsirolimus With Irinotecan
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Temsirolimus With Irinotecan
Affected / at Risk (%) # Events
Total   1/4 (25.00%)    
Blood and lymphatic system disorders   
Hemorrhage, pulmonary/upper respiratory, Lung (Pulmonary Hemorrhage) * 1  1/4 (25.00%)  1
Metabolism and nutrition disorders   
AST, SGOT(serum glutamic oxaloacetic transaminase) * 1  1/4 (25.00%)  1
Tumor lysis syndrome * 1  1/4 (25.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Temsirolimus With Irinotecan
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin * 1  4/4 (100.00%)  25
Hemorrhage, pulmonary/upper respiratory * 1  1/4 (25.00%)  1
Leukocytes (total WBC) * 1  4/4 (100.00%)  25
Neutrophils/granulocytes (ANC/AGC) * 1  4/4 (100.00%)  25
Platelets * 1  4/4 (100.00%)  22
Gastrointestinal disorders   
Anorexia * 1  3/4 (75.00%)  4
Ascites (non-malignant) * 1  1/4 (25.00%)  1
Colitis * 1  1/4 (25.00%)  1
Dehydration * 1  1/4 (25.00%)  1
Diarrhea * 1  1/4 (25.00%)  3
Distension/bloating, abdominal * 1  1/4 (25.00%)  1
Mucositis/stomatitis (functional/symptomatic), Oral cavity * 1  1/4 (25.00%)  1
Vomiting * 1  1/4 (25.00%)  1
General disorders   
Fatigue (asthenia, lethargy, malaise) * 1  1/4 (25.00%)  1
Pain, Abdomen NOS, Bone, Extremity, Limb, Oral Cavity * 1  4/4 (100.00%)  5
Phosphate, serum-low (hypophosphatemia) * 1  4/4 (100.00%)  11
Weight gain * 1  1/4 (25.00%)  1
Immune system disorders   
Allergic reaction/hypersensitivity (including drug fever) * 1  1/4 (25.00%)  1
Infections and infestations   
Colitis, infectious (e.g., Clostridium difficile) * 1  2/4 (50.00%)  3
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe * 1  4/4 (100.00%)  16
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e * 1  3/4 (75.00%)  7
Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related, Wound * 1  1/4 (25.00%)  2
Metabolism and nutrition disorders   
AST, SGOT(serum glutamic oxaloacetic transaminase) * 1  1/4 (25.00%)  2
Acidosis (metabolic or respiratory) * 1  1/4 (25.00%)  1
Alkalosis (metabolic or respiratory) * 1  1/4 (25.00%)  2
Bilirubin (hyperbilirubinemia) * 1  1/4 (25.00%)  1
Calcium, serum-low (hypocalcemia) * 1  2/4 (50.00%)  2
Glucose, serum-high (hyperglycemia) * 1  1/4 (25.00%)  2
Potassium, serum-high (hyperkalemia) * 1  1/4 (25.00%)  1
Potassium, serum-low (hypokalemia) * 1  1/4 (25.00%)  10
Proteinuria * 1  1/4 (25.00%)  1
Sodium, serum-low (hyponatremia) * 1  2/4 (50.00%)  3
Triglyceride, serum-high (hypertriglyceridemia) * 1  1/4 (25.00%)  1
Uric acid, serum-high (hyperuricemia) * 1  1/4 (25.00%)  1
Renal and urinary disorders   
Cystitis * 1  1/4 (25.00%)  1
Renal failure * 1  1/4 (25.00%)  1
Urinary frequency/urgency * 1  1/4 (25.00%)  1
Respiratory, thoracic and mediastinal disorders   
Adult Respiratory Distress Syndrome (ARDS) * 1  1/4 (25.00%)  1
Cough * 1  1/4 (25.00%)  1
Pleural effusion (non-malignant) * 1  1/4 (25.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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.
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
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