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Trial record 86 of 163 for:    ISOTRETINOIN

Induction Therapy Including 131 I-MIBG and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing Stem Cell Transplant, Radiation Therapy, and Maintenance Therapy With Isotretinoin

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ClinicalTrials.gov Identifier: NCT01175356
Recruitment Status : Completed
First Posted : August 4, 2010
Results First Posted : September 28, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Disseminated Neuroblastoma
Ganglioneuroblastoma
Localized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Regional Neuroblastoma
Stage 4S Neuroblastoma
Interventions Drug: cyclophosphamide
Drug: topotecan hydrochloride
Drug: cisplatin
Drug: etoposide phosphate
Drug: vincristine sulfate
Drug: doxorubicin hydrochloride
Radiation: iobenguane I 131
Procedure: therapeutic conventional surgery
Drug: busulfan
Drug: melphalan
Procedure: autologous hematopoietic stem cell transplantation
Procedure: in vitro-treated peripheral blood stem cell transplantation
Radiation: 3-dimensional conformal radiation therapy
Radiation: external beam radiation therapy
Radiation: intensity-modulated radiation therapy
Drug: isotretinoin
Other: pharmacological study
Other: questionnaire administration
Other: laboratory biomarker analysis
Enrollment 99
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (131I-MIBG, Chemotherapy)
Hide Arm/Group Description Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
Period Title: Overall Study
Started 99
Completed 18
Not Completed 81
Reason Not Completed
Death             1
Lack of Efficacy             12
Lost to Follow-up             1
Physician Decision             23
Ineligible             1
Treatment Slot Not Available             18
Refusal by patient/parent/guardian             6
Pts MIBG non-avid after enrollment             2
On other COG study w/tumor tx intent             7
Inadequate stem cell for transplant             1
Initiation other tx prior to completion             9
Arm/Group Title Treatment (131I-MIBG, Chemotherapy)
Hide Arm/Group Description Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
Overall Number of Baseline Participants 99
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants
<=18 years
99
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 99 participants
4.2  (2.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants
Female
39
  39.4%
Male
60
  60.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants
Hispanic or Latino
6
   6.1%
Not Hispanic or Latino
86
  86.9%
Unknown or Not Reported
7
   7.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants
American Indian or Alaska Native
1
   1.0%
Asian
3
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
18
  18.2%
White
64
  64.6%
More than one race
0
   0.0%
Unknown or Not Reported
13
  13.1%
1.Primary Outcome
Title Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131
Hide Description Number of MIBG avid patients who receive 131I-MIBG divided by the number of patients evaluable for the feasibility of MIBG endpoint x 100%.
Time Frame Up to 6 weeks after course 5 of induction
Hide Outcome Measure Data
Hide Analysis Population Description
Includes patients who met criteria to receive 131I-MIBG but went off protocol therapy before receiving a dose assignment, but excludes patients that could not continue onto 131I-MIBG therapy due to lack of an open treatment slot. The definition of receiving MIBG labeled with iodine-131 is receiving 131I-MIBG.
Arm/Group Title Treatment (131I-MIBG, Chemotherapy)
Hide Arm/Group Description:
Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
Overall Number of Participants Analyzed 68
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
86.8
(76.7 to 92.9)
2.Primary Outcome
Title Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy
Hide Description Number of MIBG avid patients who receive 131I-MIBG and Bu/Mel divided by the number of patients evaluable for the feasibility of MIBG and Bu/Mel consolidation endpoint x 100%.
Time Frame Up to day -6 of conditioning
Hide Outcome Measure Data
Hide Analysis Population Description
Includes patients who met criteria to receive 131I-MIBG but went off protocol therapy before receiving a dose assignment, but excludes patients that could not receive 131I-MIBG therapy due to lack of an open treatment slot. The definition of receiving Bu/Mel conditioning is receiving the first dose of planned Busulfan on Day -6 of conditioning.
Arm/Group Title Treatment (131I-MIBG, Chemotherapy)
Hide Arm/Group Description:
Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
82.2
(68.7 to 90.7)
3.Secondary Outcome
Title Incidence of Unacceptable Toxicity and Sinusoidal Obstruction Syndrome (SOS), Assessed by Common Terminology Criteria (CTV)v.4.0 for Toxicity Assessment and Grading for I-MIBG
Hide Description Number of patients who had an unacceptable toxicity or experienced SOS. Unacceptable toxicity was defined as CTC Grade 4-5 Pulmonary/Respiratory.
Time Frame Up to 6 weeks after course 5 of induction
Hide Outcome Measure Data
Hide Analysis Population Description
Includes patients who received 131I-MIBG therapy.
Arm/Group Title Treatment (131I-MIBG, Chemotherapy)
Hide Arm/Group Description:
Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
Overall Number of Participants Analyzed 53
Measure Type: Count of Participants
Unit of Measure: Participants
3
   5.7%
Time Frame [Not Specified]
Adverse Event Reporting Description The Total Number of Participants at Risk (n=98) in the Adverse Events tables does not match the number of patients in the Participant Flow (n=99) because ineligible patients were excluded (n=1).
 
Arm/Group Title Treatment (131I-MIBG, Chemotherapy)
Hide Arm/Group Description Induction with multi-agent chemotherapy and MIBG labeled with iodine-131/isotretinoin/vincristine followed by Consolidation with BuMel Chemotherapy+ASCT+XRT.
All-Cause Mortality
Treatment (131I-MIBG, Chemotherapy)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (131I-MIBG, Chemotherapy)
Affected / at Risk (%) # Events
Total   27/98 (27.55%)    
Cardiac disorders   
39000-Heart failure  1/98 (1.02%)  1
74500-Sinus tachycardia  1/98 (1.02%)  1
Gastrointestinal disorders   
10300-Abdominal pain  1/98 (1.02%)  1
14900-Ascites  6/98 (6.12%)  6
55600-Mucositis oral  2/98 (2.04%)  2
General disorders   
24600-Death NOS  13/98 (13.27%)  13
37200-General disorders and administration site conditions - Other specify  1/98 (1.02%)  1
55700-Multi-organ failure  2/98 (2.04%)  2
60600-Pain  1/98 (1.02%)  1
Hepatobiliary disorders   
21600-Cholecystitis  1/98 (1.02%)  1
40000-Hepatic failure  2/98 (2.04%)  2
40400-Hepatic pain  2/98 (2.04%)  2
40600-Hepatobiliary disorders - Other specify  2/98 (2.04%)  2
66500-Portal hypertension  3/98 (3.06%)  3
Infections and infestations   
44800-Infections and infestations - Other specify  2/98 (2.04%)  2
53100-Lung infection  1/98 (1.02%)  1
73700-Sepsis  3/98 (3.06%)  3
Investigations   
10900-Activated partial thromboplastin time prolonged  2/98 (2.04%)  2
11600-Alanine aminotransferase increased  4/98 (4.08%)  4
15000-Aspartate aminotransferase increased  4/98 (4.08%)  4
17400-Blood bilirubin increased  8/98 (8.16%)  8
45800-INR increased  2/98 (2.04%)  2
88200-Weight gain  5/98 (5.10%)  5
88300-Weight loss  2/98 (2.04%)  2
Metabolism and nutrition disorders   
10700-Acidosis  1/98 (1.02%)  1
13500-Anorexia  1/98 (1.02%)  1
41600-Hyperkalemia  1/98 (1.02%)  1
41800-Hypernatremia  1/98 (1.02%)  1
42600-Hypoalbuminemia  2/98 (2.04%)  2
43100-Hypokalemia  2/98 (2.04%)  3
43300-Hyponatremia  3/98 (3.06%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
58000-Neoplasms benign malignant and unspecified (incl cysts and polyps) - Other specify  1/98 (1.02%)  1
Nervous system disorders   
72500-Reversible posterior leukoencephalopathy syndrome  1/98 (1.02%)  1
Respiratory, thoracic and mediastinal disorders   
43900-Hypoxia  5/98 (5.10%)  5
65900-Pleural effusion  3/98 (3.06%)  3
69000-Pulmonary hypertension  1/98 (1.02%)  1
71600-Respiratory thoracic and mediastinal disorders - Other specify  1/98 (1.02%)  1
Vascular disorders   
43600-Hypotension  1/98 (1.02%)  1
1
Term from vocabulary, CTCv4
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (131I-MIBG, Chemotherapy)
Affected / at Risk (%) # Events
Total   86/98 (87.76%)    
Blood and lymphatic system disorders   
13200-Anemia  24/98 (24.49%)  49
33300-Febrile neutropenia  54/98 (55.10%)  81
Cardiac disorders   
20000-Cardiac arrest  1/98 (1.02%)  1
78900-Supraventricular tachycardia  1/98 (1.02%)  1
Ear and labyrinth disorders   
38900-Hearing impaired  9/98 (9.18%)  11
Gastrointestinal disorders   
10100-Abdominal distension  1/98 (1.02%)  1
10300-Abdominal pain  7/98 (7.14%)  7
14900-Ascites  5/98 (5.10%)  5
22100-Colitis  1/98 (1.02%)  1
25700-Diarrhea  6/98 (6.12%)  7
29400-Enterocolitis  1/98 (1.02%)  1
36400-Gastritis  1/98 (1.02%)  1
44600-Ileus  1/98 (1.02%)  1
55600-Mucositis oral  19/98 (19.39%)  22
57600-Nausea  15/98 (15.31%)  17
59700-Oral pain  2/98 (2.04%)  2
81900-Typhlitis  1/98 (1.02%)  1
87900-Vomiting  18/98 (18.37%)  20
General disorders   
33900-Fever  1/98 (1.02%)  1
37200-General disorders and administration site conditions - Other specify  1/98 (1.02%)  1
60600-Pain  7/98 (7.14%)  8
Immune system disorders   
12000-Allergic reaction  1/98 (1.02%)  1
13100-Anaphylaxis  1/98 (1.02%)  1
Infections and infestations   
20500-Catheter related infection  10/98 (10.20%)  11
25600-Device related infection  1/98 (1.02%)  1
44800-Infections and infestations - Other specify  17/98 (17.35%)  18
53100-Lung infection  2/98 (2.04%)  2
61100-Pancreas infection  1/98 (1.02%)  1
73700-Sepsis  4/98 (4.08%)  4
74600-Sinusitis  1/98 (1.02%)  1
75200-Skin infection  1/98 (1.02%)  1
76000-Small intestine infection  1/98 (1.02%)  1
82300-Upper respiratory infection  1/98 (1.02%)  1
83100-Urinary tract infection  4/98 (4.08%)  4
88900-Wound infection  2/98 (2.04%)  2
Injury, poisoning and procedural complications   
13800-Aortic injury  1/98 (1.02%)  1
45700-Injury poisoning and procedural complications - Other specify  1/98 (1.02%)  1
47300-Intraoperative hepatobiliary injury  1/98 (1.02%)  1
47700-Intraoperative renal injury  1/98 (1.02%)  1
Investigations   
10900-Activated partial thromboplastin time prolonged  1/98 (1.02%)  1
11600-Alanine aminotransferase increased  14/98 (14.29%)  15
15000-Aspartate aminotransferase increased  14/98 (14.29%)  14
17400-Blood bilirubin increased  1/98 (1.02%)  1
24100-Creatinine increased  2/98 (2.04%)  2
34000-Fibrinogen decreased  1/98 (1.02%)  1
37500-GGT increased  1/98 (1.02%)  1
52600-Lipase increased  1/98 (1.02%)  1
53700-Lymphocyte count decreased  21/98 (21.43%)  49
58300-Neutrophil count decreased  27/98 (27.55%)  56
65800-Platelet count decreased  28/98 (28.57%)  59
88200-Weight gain  1/98 (1.02%)  1
88300-Weight loss  1/98 (1.02%)  1
88500-White blood cell decreased  23/98 (23.47%)  50
Metabolism and nutrition disorders   
10700-Acidosis  1/98 (1.02%)  1
13500-Anorexia  33/98 (33.67%)  48
24700-Dehydration  12/98 (12.24%)  12
41300-Hypercalcemia  1/98 (1.02%)  1
41400-Hyperglycemia  9/98 (9.18%)  12
41600-Hyperkalemia  2/98 (2.04%)  2
41700-Hypermagnesemia  1/98 (1.02%)  1
41800-Hypernatremia  1/98 (1.02%)  1
42600-Hypoalbuminemia  3/98 (3.06%)  3
42700-Hypocalcemia  3/98 (3.06%)  3
42900-Hypoglycemia  1/98 (1.02%)  1
43100-Hypokalemia  33/98 (33.67%)  36
43200-Hypomagnesemia  2/98 (2.04%)  2
43300-Hyponatremia  8/98 (8.16%)  9
43500-Hypophosphatemia  16/98 (16.33%)  18
54900-Metabolism and nutrition disorders - Other specify  2/98 (2.04%)  2
Musculoskeletal and connective tissue disorders   
18200-Bone pain  1/98 (1.02%)  1
37300-Generalized muscle weakness  1/98 (1.02%)  1
60700-Pain in extremity  2/98 (2.04%)  2
Nervous system disorders   
10500-Abducens nerve disorder  1/98 (1.02%)  1
38800-Headache  2/98 (2.04%)  2
79100-Syncope  1/98 (1.02%)  1
Psychiatric disorders   
11400-Agitation  2/98 (2.04%)  2
13700-Anxiety  1/98 (1.02%)  1
25400-Depression  1/98 (1.02%)  1
Renal and urinary disorders   
11100-Acute kidney injury  1/98 (1.02%)  1
39300-Hematuria  2/98 (2.04%)  2
71100-Renal calculi  1/98 (1.02%)  1
Respiratory, thoracic and mediastinal disorders   
19300-Bronchospasm  1/98 (1.02%)  1
29700-Epistaxis  3/98 (3.06%)  4
43900-Hypoxia  8/98 (8.16%)  8
64900-Pharyngeal mucositis  1/98 (1.02%)  1
66400-Pneumothorax  1/98 (1.02%)  1
68700-Pulmonary edema  2/98 (2.04%)  2
69000-Pulmonary hypertension  1/98 (1.02%)  1
71500-Respiratory failure  2/98 (2.04%)  2
78100-Stridor  1/98 (1.02%)  2
Skin and subcutaneous tissue disorders   
74700-Skin and subcutaneous tissue disorders - Other specify  1/98 (1.02%)  1
Surgical and medical procedures   
79000-Surgical and medical procedures - Other specify  1/98 (1.02%)  1
Vascular disorders   
39100-Hematoma  1/98 (1.02%)  1
42100-Hypertension  1/98 (1.02%)  2
43600-Hypotension  4/98 (4.08%)  4
1
Term from vocabulary, CTCv4
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Must obtain prior approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01175356     History of Changes
Other Study ID Numbers: ANBL09P1
NCI-2011-01745 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000682629 ( Other Identifier: ClinicalTrials.gov )
ANBL09P1 ( Other Identifier: Children's Oncology Group )
ANBL09P1 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
U10CA098543 ( U.S. NIH Grant/Contract )
First Submitted: August 3, 2010
First Posted: August 4, 2010
Results First Submitted: July 26, 2017
Results First Posted: September 28, 2017
Last Update Posted: November 6, 2017