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Trial record 43 of 163 for:    ISOTRETINOIN

Biological Therapy, Sargramostim, and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma

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: NCT01334515
Recruitment Status : Completed
First Posted : April 13, 2011
Results First Posted : February 20, 2015
Last Update Posted : June 15, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Recurrent Neuroblastoma
Interventions Biological: hu14.18-IL2 fusion protein
Drug: isotretinoin
Biological: sargramostim
Other: laboratory biomarker analysis
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Disease Measured by Standard Radiographic Criteria Disease Evaluable Only by I-MIBG or BM Histology
Hide Arm/Group Description

Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.

hu14.18-IL2 fusion protein: Given IV

isotretinoin: Given PO

sargramostim: Given SC

laboratory biomarker analysis: Correlative studies

Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.

hu14.18-IL2 fusion protein: Given IV

isotretinoin: Given PO

sargramostim: Given SC

laboratory biomarker analysis: Correlative studies

Period Title: Overall Study
Started 16 36
Completed 4 7
Not Completed 12 29
Reason Not Completed
Adverse Event             1             6
Death             1             0
Lack of Efficacy             8             21
Physician Decision             1             1
Withdrawal by Subject             1             1
Arm/Group Title Disease Measured by Standard Radiographic Criteria Disease Evaluable Only by I-MIBG or BM Histology Total
Hide Arm/Group Description

Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.

hu14.18-IL2 fusion protein: Given IV

isotretinoin: Given PO

sargramostim: Given SC

laboratory biomarker analysis: Correlative studies

Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.

hu14.18-IL2 fusion protein: Given IV

isotretinoin: Given PO

sargramostim: Given SC

laboratory biomarker analysis: Correlative studies

Total of all reporting groups
Overall Number of Baseline Participants 16 36 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 16 participants 36 participants 52 participants
6.94
(4.30 to 9.80)
8.75
(5.79 to 12.38)
8.31
(5.39 to 11.37)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 36 participants 52 participants
<=18 years
15
  93.8%
32
  88.9%
47
  90.4%
Between 18 and 65 years
1
   6.3%
4
  11.1%
5
   9.6%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 36 participants 52 participants
Female
6
  37.5%
12
  33.3%
18
  34.6%
Male
10
  62.5%
24
  66.7%
34
  65.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 36 participants 52 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   2.8%
1
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  18.8%
3
   8.3%
6
  11.5%
White
11
  68.8%
25
  69.4%
36
  69.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
  12.5%
7
  19.4%
9
  17.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 36 participants 52 participants
Hispanic or Latino
5
  31.3%
3
   8.3%
8
  15.4%
Not Hispanic or Latino
11
  68.8%
30
  83.3%
41
  78.8%
Unknown or Not Reported
0
   0.0%
3
   8.3%
3
   5.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 36 participants 52 participants
United States 14 33 47
Canada 2 3 5
1.Primary Outcome
Title Number of Patients With Unacceptable Dose Limiting Toxicities (DLTs)
Hide Description Test for tolerability and monitor for the occurrence of too many unacceptable DLTs using a two-stage stopping rule: (Stage 1) Accrue 10 patients. If more than 1 experience at least one unacceptable DLT during the first treatment cycle, the regimen will be considered to have unacceptable toxicity, and accrual will be temporarily closed, to review all relevant data and consider modifying the regimen to improve safety. If 1 or no patients have an unacceptable DLT in the first treatment cycle, then continue. (Stage 2) Accrue 20 more patients. If 7 or more experience at least one unacceptable DLT in the first treatment cycle, temporarily close the study for possible dosing-safety modifications. If 6 or fewer have an unacceptable DLT in the first treatment cycle, it is reasonable to assume that the combination therapy is safe.
Time Frame Up to 10 courses
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure evaluates the first 30 patients to enroll and who receive at least one dose of hu14.18-IL2.
Arm/Group Title Disease Measured by Standard Radiographic Criteria Disease Evaluable Only by I-MIBG or BM Histology
Hide Arm/Group Description:

Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.

hu14.18-IL2 fusion protein: Given IV

isotretinoin: Given PO

sargramostim: Given SC

laboratory biomarker analysis: Correlative studies

Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.

hu14.18-IL2 fusion protein: Given IV

isotretinoin: Given PO

sargramostim: Given SC

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 10 20
Measure Type: Number
Unit of Measure: participants
Patients with Unacceptable DLTs 1 2
Patients without Unacceptable DLTs 9 18
2.Secondary Outcome
Title Overall Response Evaluated in This Study Using the New International Criteria Proposed by the Revised Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description Number of patients where best overall response is a complete response (CR)-[disappearance of all target lesions and disappearance of any other measureable disease], a very Good Partial Response (VGPR)- [>90% decrease of the disease measurement for CT/MRI lesions, taking as reference the disease measurement done to confirm measurable disease at study entry. Non-target CT/MRI lesions stable to smaller in size], or partial Response (PR)- [>= 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry. Non-target CT/MRI lesions stable to smaller in size], and maintains the response. It is possible that a subject’s response to therapy may not occur until after several months of treatment. In order to prevent bias, the maximum duration of time/treatment over which a subject’s response is to be assessed for determination of the best overall response is after the completion of up to 10 courses.
Time Frame Every two cycles (each cycle lasts 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients will be evaluable for inclusion in the analysis of response if they have an event at any time on the study or if they complete at least 2 cycles of hu14.18-IL2 therapy. Patients who go off-protocol therapy prior to the completion of 2 cycles due to parent/family choice and/or due to toxicity will not be considered evaluable for response.
Arm/Group Title Disease Measured by Standard Radiographic Criteria Disease Evaluable Only by I-MIBG or BM Histology
Hide Arm/Group Description:

Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.

hu14.18-IL2 fusion protein: Given IV

isotretinoin: Given PO

sargramostim: Given SC

laboratory biomarker analysis: Correlative studies

Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.

hu14.18-IL2 fusion protein: Given IV

isotretinoin: Given PO

sargramostim: Given SC

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 15 30
Measure Type: Number
Unit of Measure: participants
Responders 1 6
Non-Responders 14 24
Time Frame [Not Specified]
Adverse Event Reporting Description SAE field contains NCI Common Toxicity Criteria for Adverse Effects (CTCAE) submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs. Only Grade 3 and higher Adverse Events were collected/assessed in this study.
 
Arm/Group Title Disease Measured by Standard Radiographic Criteria Disease Evaluable Only by I-MIBG or BM Histology
Hide Arm/Group Description

Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.

hu14.18-IL2 fusion protein: Given IV

isotretinoin: Given PO

sargramostim: Given SC

laboratory biomarker analysis: Correlative studies

Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.

hu14.18-IL2 fusion protein: Given IV

isotretinoin: Given PO

sargramostim: Given SC

laboratory biomarker analysis: Correlative studies

All-Cause Mortality
Disease Measured by Standard Radiographic Criteria Disease Evaluable Only by I-MIBG or BM Histology
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Disease Measured by Standard Radiographic Criteria Disease Evaluable Only by I-MIBG or BM Histology
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/16 (43.75%)      18/36 (50.00%)    
Blood and lymphatic system disorders     
Anemia  1/16 (6.25%)  1 0/36 (0.00%)  0
Gastrointestinal disorders     
Vomiting  0/16 (0.00%)  0 1/36 (2.78%)  1
General disorders     
Death NOS  1/16 (6.25%)  1 0/36 (0.00%)  0
Fever  0/16 (0.00%)  0 2/36 (5.56%)  2
Malaise  0/16 (0.00%)  0 1/36 (2.78%)  1
Pain  1/16 (6.25%)  1 2/36 (5.56%)  2
Investigations     
Alanine aminotransferase increased  0/16 (0.00%)  0 3/36 (8.33%)  3
Aspartate aminotransferase increased  0/16 (0.00%)  0 3/36 (8.33%)  3
Blood bilirubin increased  4/16 (25.00%)  5 6/36 (16.67%)  7
GGT increased  0/16 (0.00%)  0 1/36 (2.78%)  1
Platelet count decreased  0/16 (0.00%)  0 1/36 (2.78%)  1
Metabolism and nutrition disorders     
Anorexia  0/16 (0.00%)  0 1/36 (2.78%)  1
Dehydration  0/16 (0.00%)  0 1/36 (2.78%)  1
Hypercalcemia  1/16 (6.25%)  1 0/36 (0.00%)  0
Hypoalbuminemia  1/16 (6.25%)  1 0/36 (0.00%)  0
Hypocalcemia  1/16 (6.25%)  1 1/36 (2.78%)  1
Hypokalemia  1/16 (6.25%)  2 1/36 (2.78%)  1
Hypophosphatemia  1/16 (6.25%)  1 0/36 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1/16 (6.25%)  1 0/36 (0.00%)  0
Nervous system disorders     
Depressed level of consciousness  0/16 (0.00%)  0 1/36 (2.78%)  1
Respiratory, thoracic and mediastinal disorders     
Hypoxia  1/16 (6.25%)  1 1/36 (2.78%)  1
Pleural effusion  1/16 (6.25%)  1 0/36 (0.00%)  0
Respiratory failure  0/16 (0.00%)  0 1/36 (2.78%)  1
Sore throat  0/16 (0.00%)  0 1/36 (2.78%)  1
Skin and subcutaneous tissue disorders     
Erythroderma  0/16 (0.00%)  0 1/36 (2.78%)  1
Rash maculo-papular  1/16 (6.25%)  1 0/36 (0.00%)  0
Vascular disorders     
Capillary leak syndrome  3/16 (18.75%)  4 2/36 (5.56%)  2
Hypotension  1/16 (6.25%)  1 1/36 (2.78%)  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%
Disease Measured by Standard Radiographic Criteria Disease Evaluable Only by I-MIBG or BM Histology
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/16 (81.25%)      31/36 (86.11%)    
Blood and lymphatic system disorders     
Anemia  9/16 (56.25%)  11 11/36 (30.56%)  11
Febrile neutropenia  0/16 (0.00%)  0 1/36 (2.78%)  1
Cardiac disorders     
Cardiac disorders - Other  0/16 (0.00%)  0 1/36 (2.78%)  1
Mitral valve disease  0/16 (0.00%)  0 1/36 (2.78%)  1
Ear and labyrinth disorders     
Hearing impaired  0/16 (0.00%)  0 3/36 (8.33%)  3
Eye disorders     
Eye disorders - Other  0/16 (0.00%)  0 1/36 (2.78%)  1
Photophobia  0/16 (0.00%)  0 1/36 (2.78%)  1
Gastrointestinal disorders     
Abdominal pain  1/16 (6.25%)  2 5/36 (13.89%)  5
Gastroesophageal reflux disease  0/16 (0.00%)  0 1/36 (2.78%)  1
Nausea  0/16 (0.00%)  0 2/36 (5.56%)  3
Small intestinal obstruction  1/16 (6.25%)  1 0/36 (0.00%)  0
Vomiting  0/16 (0.00%)  0 1/36 (2.78%)  1
General disorders     
Fatigue  2/16 (12.50%)  2 0/36 (0.00%)  0
Fever  1/16 (6.25%)  1 10/36 (27.78%)  22
Pain  2/16 (12.50%)  2 6/36 (16.67%)  10
Immune system disorders     
Allergic reaction  0/16 (0.00%)  0 2/36 (5.56%)  2
Infections and infestations     
Catheter related infection  0/16 (0.00%)  0 2/36 (5.56%)  3
Enterocolitis infectious  1/16 (6.25%)  1 0/36 (0.00%)  0
Infections and infestations - Other  2/16 (12.50%)  4 1/36 (2.78%)  1
Lung infection  0/16 (0.00%)  0 1/36 (2.78%)  1
Otitis media  1/16 (6.25%)  1 0/36 (0.00%)  0
Upper respiratory infection  1/16 (6.25%)  1 1/36 (2.78%)  1
Investigations     
Alanine aminotransferase increased  3/16 (18.75%)  4 14/36 (38.89%)  20
Alkaline phosphatase increased  2/16 (12.50%)  2 0/36 (0.00%)  0
Aspartate aminotransferase increased  2/16 (12.50%)  2 11/36 (30.56%)  13
Blood bilirubin increased  2/16 (12.50%)  4 4/36 (11.11%)  10
GGT increased  0/16 (0.00%)  0 2/36 (5.56%)  4
Lymphocyte count decreased  2/16 (12.50%)  3 10/36 (27.78%)  16
Neutrophil count decreased  2/16 (12.50%)  2 5/36 (13.89%)  6
Platelet count decreased  5/16 (31.25%)  7 11/36 (30.56%)  20
Weight gain  0/16 (0.00%)  0 1/36 (2.78%)  1
Weight loss  1/16 (6.25%)  1 0/36 (0.00%)  0
White blood cell decreased  1/16 (6.25%)  2 8/36 (22.22%)  9
Metabolism and nutrition disorders     
Anorexia  0/16 (0.00%)  0 3/36 (8.33%)  3
Hyperglycemia  5/16 (31.25%)  5 2/36 (5.56%)  4
Hypernatremia  1/16 (6.25%)  1 0/36 (0.00%)  0
Hypertriglyceridemia  1/16 (6.25%)  1 2/36 (5.56%)  2
Hypoalbuminemia  2/16 (12.50%)  2 2/36 (5.56%)  2
Hypocalcemia  2/16 (12.50%)  2 2/36 (5.56%)  3
Hypokalemia  2/16 (12.50%)  2 6/36 (16.67%)  9
Hypomagnesemia  0/16 (0.00%)  0 1/36 (2.78%)  1
Hyponatremia  1/16 (6.25%)  2 0/36 (0.00%)  0
Hypophosphatemia  2/16 (12.50%)  4 3/36 (8.33%)  6
Metabolism and nutrition disorders - Other  0/16 (0.00%)  0 1/36 (2.78%)  1
Obesity  0/16 (0.00%)  0 1/36 (2.78%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1/16 (6.25%)  1 2/36 (5.56%)  3
Bone pain  0/16 (0.00%)  0 3/36 (8.33%)  3
Buttock pain  0/16 (0.00%)  0 1/36 (2.78%)  1
Musculoskeletal and connective tissue disorder - Other  0/16 (0.00%)  0 1/36 (2.78%)  1
Neck pain  0/16 (0.00%)  0 1/36 (2.78%)  1
Pain in extremity  0/16 (0.00%)  0 2/36 (5.56%)  2
Nervous system disorders     
Headache  0/16 (0.00%)  0 1/36 (2.78%)  1
Psychiatric disorders     
Anxiety  1/16 (6.25%)  1 0/36 (0.00%)  0
Insomnia  0/16 (0.00%)  0 1/36 (2.78%)  1
Renal and urinary disorders     
Renal and urinary disorders - Other  0/16 (0.00%)  0 1/36 (2.78%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  0/16 (0.00%)  0 1/36 (2.78%)  1
Hypoxia  1/16 (6.25%)  1 4/36 (11.11%)  10
Nasal congestion  0/16 (0.00%)  0 1/36 (2.78%)  1
Pleural effusion  1/16 (6.25%)  1 0/36 (0.00%)  0
Pneumonitis  0/16 (0.00%)  0 1/36 (2.78%)  1
Skin and subcutaneous tissue disorders     
Dry skin  0/16 (0.00%)  0 1/36 (2.78%)  1
Pruritus  0/16 (0.00%)  0 1/36 (2.78%)  1
Rash maculo-papular  0/16 (0.00%)  0 2/36 (5.56%)  2
Vascular disorders     
Capillary leak syndrome  1/16 (6.25%)  1 3/36 (8.33%)  3
Hypotension  0/16 (0.00%)  0 7/36 (19.44%)  7
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 Sponsor approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 352-273-0567
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01334515     History of Changes
Other Study ID Numbers: ANBL1021
NCI-2011-02672 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000698589 ( Other Identifier: Clinical Trials.gov )
U10CA098543 ( U.S. NIH Grant/Contract )
COG-ANBL1021 ( Other Identifier: Children's Oncology Group )
First Submitted: April 12, 2011
First Posted: April 13, 2011
Results First Submitted: February 4, 2015
Results First Posted: February 20, 2015
Last Update Posted: June 15, 2016