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Trial record 27 of 78 for:    vismodegib

Vismodegib in Treating Patients With Recurrent or Refractory Medulloblastoma

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ClinicalTrials.gov Identifier: NCT00939484
Recruitment Status : Completed
First Posted : July 15, 2009
Results First Posted : February 25, 2016
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adult Medulloblastoma
Interventions Other: Pharmacological Study
Drug: Vismodegib
Enrollment 31
Recruitment Details This study was distributed to the sites on June 18, 2009, and received the first IRB approval on July 20, 2009. The study was closed to accrual on December 07, 2012. Thirty two (32) patients have been enrolled to the study, Last patient went off treatment in October 2013.
Pre-assignment Details Total 32 patients were registered on this study, 8 in Stratum A, 21 in Stratum B and 3 in Stratum C. One patient in Stratum B was declared ineligible.
Arm/Group Title Stratum A (PTCH/SHH Pathway Inactivated) Stratum B (PTCH/SHH Pathway Activated) Stratum C (Unknown PTCH/SHH Pathway Activation)
Hide Arm/Group Description Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
Period Title: Overall Study
Started 8 20 3
Completed 0 0 0
Not Completed 8 20 3
Reason Not Completed
Progression/Relapse             8             20             3
Arm/Group Title Stratum A (PTCH/SHH Pathway Inactivated) Stratum B (PTCH/SHH Pathway Activated) Stratum C (Unknown PTCH/SHH Pathway Activation) Total
Hide Arm/Group Description Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status Total of all reporting groups
Overall Number of Baseline Participants 8 20 3 31
Hide Baseline Analysis Population Description
One patient in Stratum B was ineligible for the study and thus was not included in the baseline table.
Age, Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants 20 participants 3 participants 31 participants
23.8
(22.4 to 40.6)
32.0
(23.5 to 51.9)
32.9
(25.3 to 38.6)
30.3
(22.4 to 51.9)
[1]
Measure Description: Age at study enrollment
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 20 participants 3 participants 31 participants
Female
2
  25.0%
9
  45.0%
2
  66.7%
13
  41.9%
Male
6
  75.0%
11
  55.0%
1
  33.3%
18
  58.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 20 participants 3 participants 31 participants
Hispanic or Latino
0
   0.0%
1
   5.0%
1
  33.3%
2
   6.5%
Not Hispanic or Latino
7
  87.5%
18
  90.0%
2
  66.7%
27
  87.1%
Unknown or Not Reported
1
  12.5%
1
   5.0%
0
   0.0%
2
   6.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 20 participants 3 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
3
  15.0%
0
   0.0%
3
   9.7%
White
7
  87.5%
16
  80.0%
3
 100.0%
26
  83.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  12.5%
1
   5.0%
0
   0.0%
2
   6.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 20 participants 3 participants 31 participants
8 20 3 31
Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 20 participants 3 participants 31 participants
Desmoplastic medulloblastoma 0 1 0 1
Medulloblastoma, NOS 8 18 3 29
Primitive neuroectodermal tumor 0 1 0 1
1.Primary Outcome
Title Objective Response (CR+PR) Sustained for ≥ 8 Weeks
Hide Description Objective response is either a complete response or a partial response sustained for 8 weeks in a patient. The objective response rate will be reported separately for patients of each stratum. CR is complete disappearance of all enhancing tumor. PR is >= 50% reduction in tumor size.
Time Frame Up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stratum A (PTCH/SHH Pathway Inactivated) Stratum B (PTCH/SHH Pathway Activated) Stratum C (Unknown PTCH/SHH Pathway Activation)
Hide Arm/Group Description:
Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
Overall Number of Participants Analyzed 8 20 3
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0
(0 to 0.37)
0.15
(0.03 to 0.38)
0
(0 to 0.71)
2.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival (PFS) is measured from the date of initial treatment with GDC-0449 until the earliest of progression or death on study. PFS is censored at the last tumor assessment date for patients without disease progression who have not died within 30 days of last exposure to study treatment. Kaplan-Meier method is used to estimate the progression-free survival.
Time Frame From start of treatment up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stratum A (PTCH/SHH Pathway Inactivated) Stratum B (PTCH/SHH Pathway Activated) Stratum C (Unknown PTCH/SHH Pathway Activation)
Hide Arm/Group Description:
Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
Overall Number of Participants Analyzed 8 20 3
Median (95% Confidence Interval)
Unit of Measure: months
1.64
(0.43 to 1.84)
2.76
(1.38 to 6.38)
1.48
(1.38 to 1.84)
3.Secondary Outcome
Title Duration of Objective Response
Hide Description The duration of objective response is measured from the initial scan documenting complete or partial response that was subsequently confirmed until the earlier of documented progression or death on study. Duration of objective response is censored at the last tumor assessment date for patients without disease progression who have not died within 30 days of last exposure to study treatment.
Time Frame From start of treatment up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with sustained objective response
Arm/Group Title Stratum B (PTCH/SHH Pathway Activated)
Hide Arm/Group Description:
Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
Overall Number of Participants Analyzed 3
Median (Full Range)
Unit of Measure: months
4.59
(1.48 to 4.77)
4.Secondary Outcome
Title Pharmacokinetic Parameters of Vismodegib, CSF Penetration
Hide Description The estimated median of cerebrospinal fluid (CSF) drug penetration is reported when expressed as an AUC ratio of CSF vismodegib to that of unbound drug in plasma.
Time Frame up to 12 month
Hide Outcome Measure Data
Hide Analysis Population Description
The calculation of drug penetration is based on patients who had the course 1 plasma and CSF drug concentration data
Arm/Group Title PBTC025B
Hide Arm/Group Description:
Adult patients with a histologically confirmed diagnosis of medulloblastoma (including posterior fossa PNET) that is recurrent, progressive, or refractory.
Overall Number of Participants Analyzed 28
Median (Full Range)
Unit of Measure: ratio
0.12
(0.03 to 0.28)
Time Frame Adverse events were collected non-systematically for each of the participants from the time of enrollment to the completion of therapy or to the time off study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stratum A (PTCH/SHH Pathway Inactivated) Stratum B (PTCH/SHH Pathway Activated) Stratum C (Unknown PTCH/SHH Pathway Activation)
Hide Arm/Group Description Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
All-Cause Mortality
Stratum A (PTCH/SHH Pathway Inactivated) Stratum B (PTCH/SHH Pathway Activated) Stratum C (Unknown PTCH/SHH Pathway Activation)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Stratum A (PTCH/SHH Pathway Inactivated) Stratum B (PTCH/SHH Pathway Activated) Stratum C (Unknown PTCH/SHH Pathway Activation)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/8 (62.50%)      12/20 (60.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders       
Anemia  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Ear and labyrinth disorders       
Ear pain  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Middle ear inflammation  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal disorders       
Dyspepsia  1  0/8 (0.00%)  0 0/20 (0.00%)  0 2/3 (66.67%)  2
General disorders       
Death NOS  1  1/8 (12.50%)  1 2/20 (10.00%)  2 2/3 (66.67%)  2
Fever  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Infections and infestations       
Catheter related infection  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Lung infection  1  2/8 (25.00%)  2 0/20 (0.00%)  0 0/3 (0.00%)  0
Urinary tract infection  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Injury, poisoning and procedural complications       
Fall  1  0/8 (0.00%)  0 1/20 (5.00%)  1 0/3 (0.00%)  0
Investigations       
Alanine aminotransferase increased  1  0/8 (0.00%)  0 1/20 (5.00%)  1 0/3 (0.00%)  0
GGT increased  1  0/8 (0.00%)  0 1/20 (5.00%)  1 0/3 (0.00%)  0
Weight loss  1  0/8 (0.00%)  0 1/20 (5.00%)  1 0/3 (0.00%)  0
White blood cell decreased  1  0/8 (0.00%)  0 1/20 (5.00%)  1 0/3 (0.00%)  0
Metabolism and nutrition disorders       
Anorexia  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Dehydration  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Hypophosphatemia  1  0/8 (0.00%)  0 1/20 (5.00%)  1 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Muscle weakness lower limb  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Muscle weakness trunk  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Myalgia  1  0/8 (0.00%)  0 1/20 (5.00%)  2 0/3 (0.00%)  0
Nervous system disorders       
Headache  1  2/8 (25.00%)  2 3/20 (15.00%)  3 0/3 (0.00%)  0
Hypoglossal nerve disorder  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Nystagmus  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Peripheral motor neuropathy  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Seizure  1  2/8 (25.00%)  2 1/20 (5.00%)  1 1/3 (33.33%)  2
Somnolence  1  0/8 (0.00%)  0 1/20 (5.00%)  1 0/3 (0.00%)  0
Syncope  1  1/8 (12.50%)  1 0/20 (0.00%)  0 1/3 (33.33%)  1
Renal and urinary disorders       
Urinary incontinence  1  0/8 (0.00%)  0 1/20 (5.00%)  1 0/3 (0.00%)  0
Urinary retention  1  0/8 (0.00%)  0 1/20 (5.00%)  1 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Aspiration  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Dyspnea  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Vascular disorders       
Hypotension  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Thromboembolic event  1  0/8 (0.00%)  0 1/20 (5.00%)  1 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stratum A (PTCH/SHH Pathway Inactivated) Stratum B (PTCH/SHH Pathway Activated) Stratum C (Unknown PTCH/SHH Pathway Activation)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/8 (100.00%)      20/20 (100.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders       
Anemia  1  3/8 (37.50%)  3 4/20 (20.00%)  8 1/3 (33.33%)  2
Cardiac disorders       
Cardiac disorders - Other, specify[Right Bundle Branch Block]  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Palpitations  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Sinus bradycardia  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Sinus tachycardia  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Ear and labyrinth disorders       
Ear pain  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Tinnitus  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Eye disorders       
Blurred vision  1  0/8 (0.00%)  0 2/20 (10.00%)  2 0/3 (0.00%)  0
Eye disorders - Other, specify[Bilateral Proptosis]  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Eye disorders - Other, specify[assymetric pupils and conjunctival injection]  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  0/8 (0.00%)  0 3/20 (15.00%)  4 0/3 (0.00%)  0
Constipation  1  2/8 (25.00%)  2 2/20 (10.00%)  3 2/3 (66.67%)  2
Diarrhea  1  1/8 (12.50%)  1 7/20 (35.00%)  11 1/3 (33.33%)  2
Dysphagia  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Fecal incontinence  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Gastritis  1  1/8 (12.50%)  1 1/20 (5.00%)  1 1/3 (33.33%)  1
Nausea  1  2/8 (25.00%)  2 6/20 (30.00%)  8 1/3 (33.33%)  1
Vomiting  1  0/8 (0.00%)  0 7/20 (35.00%)  12 3/3 (100.00%)  6
General disorders       
Chills  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Fatigue  1  5/8 (62.50%)  5 8/20 (40.00%)  12 0/3 (0.00%)  0
Fever  1  2/8 (25.00%)  2 0/20 (0.00%)  0 0/3 (0.00%)  0
Gait disturbance  1  0/8 (0.00%)  0 0/20 (0.00%)  0 1/3 (33.33%)  1
General disorders and administration site conditions - Other, specify[presssure back of head]  1  0/8 (0.00%)  0 0/20 (0.00%)  0 1/3 (33.33%)  1
Malaise  1  1/8 (12.50%)  1 1/20 (5.00%)  1 0/3 (0.00%)  0
Pain  1  1/8 (12.50%)  1 0/20 (0.00%)  0 1/3 (33.33%)  1
Infections and infestations       
Upper respiratory infection  1  0/8 (0.00%)  0 3/20 (15.00%)  3 0/3 (0.00%)  0
Injury, poisoning and procedural complications       
Fall  1  0/8 (0.00%)  0 0/20 (0.00%)  0 1/3 (33.33%)  1
Investigations       
Alanine aminotransferase increased  1  0/8 (0.00%)  0 4/20 (20.00%)  6 0/3 (0.00%)  0
Aspartate aminotransferase increased  1  0/8 (0.00%)  0 6/20 (30.00%)  8 0/3 (0.00%)  0
Cholesterol high  1  0/8 (0.00%)  0 2/20 (10.00%)  2 0/3 (0.00%)  0
Creatinine increased  1  0/8 (0.00%)  0 2/20 (10.00%)  2 0/3 (0.00%)  0
Lymphocyte count decreased  1  2/8 (25.00%)  2 11/20 (55.00%)  39 2/3 (66.67%)  3
Neutrophil count decreased  1  0/8 (0.00%)  0 6/20 (30.00%)  13 0/3 (0.00%)  0
Platelet count decreased  1  1/8 (12.50%)  2 7/20 (35.00%)  12 0/3 (0.00%)  0
Weight loss  1  0/8 (0.00%)  0 2/20 (10.00%)  4 0/3 (0.00%)  0
White blood cell decreased  1  0/8 (0.00%)  0 9/20 (45.00%)  26 0/3 (0.00%)  0
Metabolism and nutrition disorders       
Anorexia  1  0/8 (0.00%)  0 3/20 (15.00%)  3 0/3 (0.00%)  0
Hypercalcemia  1  0/8 (0.00%)  0 1/20 (5.00%)  1 1/3 (33.33%)  1
Hyperglycemia  1  1/8 (12.50%)  1 5/20 (25.00%)  5 1/3 (33.33%)  1
Hyperkalemia  1  0/8 (0.00%)  0 3/20 (15.00%)  3 1/3 (33.33%)  1
Hypermagnesemia  1  0/8 (0.00%)  0 2/20 (10.00%)  4 0/3 (0.00%)  0
Hypoalbuminemia  1  1/8 (12.50%)  1 4/20 (20.00%)  6 0/3 (0.00%)  0
Hypocalcemia  1  2/8 (25.00%)  2 7/20 (35.00%)  10 0/3 (0.00%)  0
Hypoglycemia  1  1/8 (12.50%)  1 7/20 (35.00%)  12 0/3 (0.00%)  0
Hypokalemia  1  2/8 (25.00%)  2 4/20 (20.00%)  7 0/3 (0.00%)  0
Hypomagnesemia  1  1/8 (12.50%)  1 5/20 (25.00%)  6 0/3 (0.00%)  0
Hyponatremia  1  1/8 (12.50%)  2 5/20 (25.00%)  6 0/3 (0.00%)  0
Hypophosphatemia  1  5/8 (62.50%)  5 6/20 (30.00%)  18 1/3 (33.33%)  2
Musculoskeletal and connective tissue disorders       
Back pain  1  2/8 (25.00%)  2 3/20 (15.00%)  3 0/3 (0.00%)  0
Generalized muscle weakness  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Muscle weakness lower limb  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Muscle weakness upper limb  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, specify[right upper extremity weakness]  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Myalgia  1  1/8 (12.50%)  1 5/20 (25.00%)  5 0/3 (0.00%)  0
Pain in extremity  1  0/8 (0.00%)  0 1/20 (5.00%)  1 1/3 (33.33%)  1
Nervous system disorders       
Ataxia  1  0/8 (0.00%)  0 4/20 (20.00%)  4 0/3 (0.00%)  0
Dizziness  1  0/8 (0.00%)  0 2/20 (10.00%)  2 1/3 (33.33%)  1
Dysgeusia  1  1/8 (12.50%)  1 9/20 (45.00%)  10 1/3 (33.33%)  1
Dysphasia  1  1/8 (12.50%)  1 1/20 (5.00%)  1 0/3 (0.00%)  0
Facial nerve disorder  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Glossopharyngeal nerve disorder  1  1/8 (12.50%)  2 0/20 (0.00%)  0 0/3 (0.00%)  0
Headache  1  2/8 (25.00%)  3 10/20 (50.00%)  12 1/3 (33.33%)  1
Paresthesia  1  0/8 (0.00%)  0 1/20 (5.00%)  1 1/3 (33.33%)  1
Peripheral motor neuropathy  1  1/8 (12.50%)  1 1/20 (5.00%)  1 0/3 (0.00%)  0
Peripheral sensory neuropathy  1  0/8 (0.00%)  0 2/20 (10.00%)  2 0/3 (0.00%)  0
Seizure  1  1/8 (12.50%)  1 1/20 (5.00%)  1 1/3 (33.33%)  1
Tremor  1  0/8 (0.00%)  0 1/20 (5.00%)  3 1/3 (33.33%)  1
Psychiatric disorders       
Delirium  1  0/8 (0.00%)  0 0/20 (0.00%)  0 1/3 (33.33%)  1
Depression  1  0/8 (0.00%)  0 2/20 (10.00%)  2 0/3 (0.00%)  0
Hallucinations  1  0/8 (0.00%)  0 0/20 (0.00%)  0 1/3 (33.33%)  1
Insomnia  1  0/8 (0.00%)  0 2/20 (10.00%)  2 0/3 (0.00%)  0
Psychiatric disorders - Other, specify[nightmare one time]  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Renal and urinary disorders       
Renal and urinary disorders - Other, specify[urinary hesitancy]  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Urinary incontinence  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Reproductive system and breast disorders       
Irregular menstruation  1  0/8 (0.00%)  0 2/20 (10.00%)  3 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis  1  0/8 (0.00%)  0 3/20 (15.00%)  3 0/3 (0.00%)  0
Cough  1  3/8 (37.50%)  4 4/20 (20.00%)  5 0/3 (0.00%)  0
Dyspnea  1  2/8 (25.00%)  2 0/20 (0.00%)  0 0/3 (0.00%)  0
Nasal congestion  1  0/8 (0.00%)  0 2/20 (10.00%)  3 0/3 (0.00%)  0
Pleuritic pain  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Pneumonitis  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Sore throat  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Voice alteration  1  1/8 (12.50%)  1 0/20 (0.00%)  0 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders       
Alopecia  1  0/8 (0.00%)  0 4/20 (20.00%)  5 0/3 (0.00%)  0
Rash acneiform  1  1/8 (12.50%)  1 1/20 (5.00%)  1 0/3 (0.00%)  0
Vascular disorders       
Hypotension  1  2/8 (25.00%)  2 0/20 (0.00%)  0 0/3 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tong Lin (Biostatistician)
Organization: St. Jude Children's Research Hospital
Phone: 9015952048
EMail: Tong.Lin@stjude.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00939484     History of Changes
Other Study ID Numbers: NCI-2012-03020
NCI-2012-03020 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PBTC-025B ( Other Identifier: Pediatric Brain Tumor Consortium )
PBTC-025B ( Other Identifier: CTEP )
U01CA081457 ( U.S. NIH Grant/Contract )
First Submitted: July 14, 2009
First Posted: July 15, 2009
Results First Submitted: December 10, 2015
Results First Posted: February 25, 2016
Last Update Posted: February 25, 2016