Trial Outcomes & Findings for Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma (NCT NCT00808899)
NCT ID: NCT00808899
Last Updated: 2017-05-30
Results Overview
The objective was to measure the efficacy and feasability of Temsirolimus and Irinotecan as measured by the objective response rate and toxicity rate.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
10 years
Results posted on
2017-05-30
Participant Flow
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.
Participant milestones
| Measure |
Temsirolimus With Irinotecan
Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Temsirolimus With Irinotecan
Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
3
|
Baseline Characteristics
Neuroblastoma Protocol 2008: Therapy for Children With Advanced Stage High Risk Neuroblastoma
Baseline characteristics by cohort
| Measure |
Temsirolimus With Irinotecan
n=4 Participants
Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
|
|---|---|
|
Age, Continuous
|
3.5 years
STANDARD_DEVIATION 1.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 yearsPopulation: The population consisted of patients eligible for enrollment onto the NB2008 protocol.
The objective was to measure the efficacy and feasability of Temsirolimus and Irinotecan as measured by the objective response rate and toxicity rate.
Outcome measures
Outcome data not reported
Adverse Events
Temsirolimus With Irinotecan
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Temsirolimus With Irinotecan
n=4 participants at risk
Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
|
|---|---|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Blood and lymphatic system disorders
Hemorrhage, pulmonary/upper respiratory, Lung (Pulmonary Hemorrhage)
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
25.0%
1/4 • Number of events 1 • 10 months
|
Other adverse events
| Measure |
Temsirolimus With Irinotecan
n=4 participants at risk
Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
|
|---|---|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
25.0%
1/4 • Number of events 2 • 10 months
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Metabolism and nutrition disorders
Alkalosis (metabolic or respiratory)
|
25.0%
1/4 • Number of events 2 • 10 months
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Gastrointestinal disorders
Anorexia
|
75.0%
3/4 • Number of events 4 • 10 months
|
|
Gastrointestinal disorders
Ascites (non-malignant)
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
50.0%
2/4 • Number of events 2 • 10 months
|
|
Gastrointestinal disorders
Colitis
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
50.0%
2/4 • Number of events 3 • 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Renal and urinary disorders
Cystitis
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Gastrointestinal disorders
Dehydration
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 3 • 10 months
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Infections and infestations
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe
|
100.0%
4/4 • Number of events 16 • 10 months
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
25.0%
1/4 • Number of events 2 • 10 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
4/4 • Number of events 25 • 10 months
|
|
Blood and lymphatic system disorders
Hemorrhage, pulmonary/upper respiratory
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e
|
75.0%
3/4 • Number of events 7 • 10 months
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related, Wound
|
25.0%
1/4 • Number of events 2 • 10 months
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
100.0%
4/4 • Number of events 25 • 10 months
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic), Oral cavity
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
100.0%
4/4 • Number of events 25 • 10 months
|
|
General disorders
Pain, Abdomen NOS, Bone, Extremity, Limb, Oral Cavity
|
100.0%
4/4 • Number of events 5 • 10 months
|
|
General disorders
Phosphate, serum-low (hypophosphatemia)
|
100.0%
4/4 • Number of events 11 • 10 months
|
|
Blood and lymphatic system disorders
Platelets
|
100.0%
4/4 • Number of events 22 • 10 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
25.0%
1/4 • Number of events 10 • 10 months
|
|
Metabolism and nutrition disorders
Proteinuria
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Renal and urinary disorders
Renal failure
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
50.0%
2/4 • Number of events 3 • 10 months
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • 10 months
|
|
General disorders
Weight gain
|
25.0%
1/4 • Number of events 1 • 10 months
|
Additional Information
Wayne L. Furman
St. Jude Children's Research Hospital
Phone: 1-866-278-5833
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place