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Lapatinib in Treating Young Patients With Recurrent or Refractory Central Nervous System Tumors

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: NCT00095940
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : February 6, 2012
Last Update Posted : May 23, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Childhood Anaplastic Astrocytoma
Recurrent Childhood Brain Stem Glioma
Recurrent Childhood Ependymoma
Recurrent Childhood Giant Cell Glioblastoma
Recurrent Childhood Glioblastoma
Recurrent Childhood Gliosarcoma
Recurrent Childhood Medulloblastoma
Recurrent Childhood Oligodendroglioma
Interventions Drug: lapatinib ditosylate
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: positron emission tomography
Procedure: magnetic resonance imaging
Enrollment 52
Recruitment Details Participants from institutions in the Pediatric Brain Tumor Consortium were enrolled between November 2006 and October 2008.
Pre-assignment Details Participants with tumors for whom surgical resection was indicated enrolled on the molecular biology phase and randomized to 1) receive lapatinib for 7-14 days pre-surgery or 2) no lapatinib pre-surgery. Those in group 2 who had measurable disease post-surgery would be included in the phase II part as well, but no participant met this criteria.
Arm/Group Title Medulloblastoma: Lapatinib Prior to Surgery Medulloblastoma: No Lapatinib Prior to Surgery Medulloblastoma: No Surgery High Grade Glioma: Lapatinib Prior to Surgery High Grade Glioma: No Lapatinib Prior to Surgery High Grade Glioma: No Surgery Ependymoma: Lapatinib Prior to Surgery Ependymoma: No Lapatnib Prior to Surgery Ependymoma: No Surgery
Hide Arm/Group Description Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives. Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives. Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives. Participants with recurrent high grade glioma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives. Participants with recurrent high grade glioma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives. Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives. Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives. Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives. Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
Period Title: Molecular Biology Phase
Started 2 2 0 [1] 0 0 0 [1] 2 2 0 [1]
Completed 2 2 0 0 0 0 2 2 0
Not Completed 0 0 0 0 0 0 0 0 0
[1]
No surgery prior to study enrollment; not eligible for the molecular biology phase
Period Title: Lapatinib Continuation/Phase II
Started 2 [1] 2 [2] 17 0 0 13 2 [1] 2 [2] 14
Completed 0 0 1 0 0 0 0 0 1
Not Completed 2 2 16 0 0 13 2 2 13
Reason Not Completed
Disease Progression             1             1             15             0             0             13             2             1             12
Withdrawal by Subject             1             1             1             0             0             0             0             0             1
Adverse Event             0             0             0             0             0             0             0             1             0
[1]
Continued to receive lapatinib but were ineligible for the phase II.
[2]
No measurable disease post surgery - ineligible for the phase II. Continued to receive lapatinib.
Arm/Group Title Medulloblastoma: Lapatinib Prior to Surgery Medulloblastoma: No Lapatinib Prior to Surgery Medulloblastoma: No Surgery High Grade Glioma: No Surgery Ependymoma: Lapatinib Prior to Surgery Ependymoma: No Lapatnib Prior to Surgery Ependymoma: No Surgery Total
Hide Arm/Group Description Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives. Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives. Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives. Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives. Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives. Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives. Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives. Total of all reporting groups
Overall Number of Baseline Participants 2 2 17 13 2 2 14 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 17 participants 13 participants 2 participants 2 participants 14 participants 52 participants
<=18 years
1
  50.0%
2
 100.0%
12
  70.6%
12
  92.3%
2
 100.0%
2
 100.0%
14
 100.0%
45
  86.5%
Between 18 and 65 years
1
  50.0%
0
   0.0%
5
  29.4%
1
   7.7%
0
   0.0%
0
   0.0%
0
   0.0%
7
  13.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 2 participants 17 participants 13 participants 2 participants 2 participants 14 participants 52 participants
11.6  (12.0) 8.7  (.27) 14.2  (5.9) 13.5  (4.5) 7.1  (1.8) 9.9  (1.8) 8.0  (4.1) 11.6  (5.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 17 participants 13 participants 2 participants 2 participants 14 participants 52 participants
Female
1
  50.0%
0
   0.0%
9
  52.9%
8
  61.5%
1
  50.0%
0
   0.0%
7
  50.0%
26
  50.0%
Male
1
  50.0%
2
 100.0%
8
  47.1%
5
  38.5%
1
  50.0%
2
 100.0%
7
  50.0%
26
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 2 participants 17 participants 13 participants 2 participants 2 participants 14 participants 52 participants
2 2 17 13 2 2 14 52
1.Primary Outcome
Title Relative Phosphorylation of ERBB2 (Molecular Biology Objective)
Hide Description Lapatinib may be able to control the growth of tumor cells. To assess the ability of lapatinib to block a molecule, the ERBB2 receptor, that signals tumor cells to divide, fresh frozen tissue from the surgical resection is processed by quantitative western blot analysis to assess the phosphorylation of ERBB2. The relative phosphorylation is a ratio of the phosphorylated ERBB2 measured in the tumor normalized to the level of total receptor protein and housekeeping protein. Lower values suggests more inhibition of the ERRB2 receptor signal and a decreased ability for tumor cell division.
Time Frame 7-14 days after starting therapy and prior to surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Participants enrolled on the molecular biology phase (MBP) and who submitted fresh frozen tissue were included in the analysis for this objective. One patient enrolled on the MBP did not provide fresh frozen tissue and was excluded. The sample size required for this objective was not met.
Arm/Group Title Lapatinib Prior to Surgery No Lapatinib Prior to Surgery
Hide Arm/Group Description:
Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.
Overall Number of Participants Analyzed 4 3
Median (Full Range)
Unit of Measure: ratio
.21
(.03 to .44)
.50
(.05 to 1.66)
2.Primary Outcome
Title Number of Participants With a Sustained Objective Response (Complete or Partial Response) (Phase II Objective)
Hide Description A complete response is defined as complete disappearance of all tumor accompanied by a stable or improving neurologic exam, and a partial response is defined as 50% or more reduction in the tumor size by bi-dimensional measurement and a stable or improving neurologic exam. The response must be sustained for at least 8 weeks. The number of patients with a sustained objective response will be reported separately for each of the three disease groups.
Time Frame From start of therapy until the earliest of disease progression, death or end of the fourth course (recurrent medulloblastoma and recurrent high grade glioma) or end of the sixth course (recurrent ependymoma)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with measureable residual disease who do not receive lapatinib prior to surgery or who do not have surgical resection of the tumor at study enrollment will be assessed for sustained objective response. Participants must have received at least one dose of lapatinib and remain on treatment for the specified time frame to be evaluable.
Arm/Group Title Recurrent Medulloblastoma Recurrent High Grade Glioma Recurrent Ependymoma
Hide Arm/Group Description:
Participants with recurrent medulloblastoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
Participants with recurrent high grade glioma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
Participants with recurrent ependymoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
Overall Number of Participants Analyzed 15 13 13
Measure Type: Number
Unit of Measure: Participants
0 0 0
3.Secondary Outcome
Title Tumor to Plasma Lapatinib Concentration (Molecular Biology Objective)
Hide Description For participants randomized to receive lapatinib 7-14 days prior to surgery, plasma samples will be obtained with the first dose of lapatinib prior to surgery. The lapatinib concentration is measured in both the plasma samples and the tumor tissue obtained at surgery. Reported is the concentration of lapatinib observed in the tumor expressed as a percentage of the concentration observed in plasma.
Time Frame First dose of lapatinib prior to surgery
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of recurrent medulloblastoma, high grade glioma, or ependymoma patients who were randomized to receive lapatinib prior to surgery, consented to the pharmacokinetic studies and received dose 1 of lapatinib.
Arm/Group Title Lapatinib Prior to Surgery
Hide Arm/Group Description:
Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
Overall Number of Participants Analyzed 3
Median (Full Range)
Unit of Measure: percent
18
(11 to 22)
4.Secondary Outcome
Title Maximum Concentration of Lapatinib in Plasma (Phase II Objective)
Hide Description Serial plasma samples for pharmacokinetic studies of lapatinib will be collected from consenting participants with the first dose of course 1.
Time Frame First dose of lapatinib in course 1
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consists of participants with recurrent medulloblastoma, high grade glioma, or ependymoma who did not have surgical resection of the tumor at study enrollment, consented to the pharmacokinetic studies, and received the first dose of lapatinib in course 1.
Arm/Group Title Lapatinib: No Surgery
Hide Arm/Group Description:
Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: nanogram/milliliter
5050
(1915 to 10500)
5.Secondary Outcome
Title Number of Participants With Tumors Expressing Total ERBB2
Hide Description Total ERBB2 expression is assessed in participants enrolled in both the molecular biology trial and the phase II trial who provided pre-treatment formalin fixed paraffin embedded tumor material. The tumor material is analyzed by immunohistochemistry for expression of total ERBB2. Low, moderate, and intense expression are combined into one group vs. no total ERBB2 expression.
Time Frame Pre-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the molecular biology trial or the phase II trial who consented to the biology studies and provided pre-treatment formalin fixed paraffin embedded tumor were included in the analysis population.
Arm/Group Title Recurrent Medulloblastoma Recurrent High Grade Glioma Recurrent Ependymoma
Hide Arm/Group Description:
Participants with recurrent medulloblastoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
Participants with recurrent high grade glioma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
Participants with recurrent ependymoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
Overall Number of Participants Analyzed 9 7 9
Measure Type: Number
Unit of Measure: Participants
1 2 7
6.Secondary Outcome
Title Number of Participants With Tumors Expressing Phosphorylated ERBB2 (Phase II Objective)
Hide Description Phosphorylated ERBB2 expression is assessed in patients who provided pre-treatment formalin fixed paraffin embedded tumor material. The tumor material is analyzed by immunohistochemistry for expression of phosphorylated ERBB2. Low, moderate, and intense expression are combined into one group vs. no phosphorylated ERBB2 expression.
Time Frame Pre-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the molecular biology trial or the phase II trial who consented to the biology studies and provided pre-treatment formalin fixed paraffin embedded tumor were included in the analysis population.
Arm/Group Title Recurrent Medulloblastoma Recurrent High Grade Glioma Recurrent Ependymoma
Hide Arm/Group Description:
Participants with recurrent medulloblastoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
Participants with recurrent high grade glioma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
Participants with recurrent ependymoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
Overall Number of Participants Analyzed 9 7 9
Measure Type: Number
Unit of Measure: Participants
1 4 6
Time Frame Adverse events (AEs) were collected from day 1 of starting treatment until 30 days after ceasing treatment (off study). AEs possibly, probably, or definitely attributed to the study drug that occured after the off study date were also collected.
Adverse Event Reporting Description One participant in the Medulloblastoma: No Surgery group did not receive any lapatinib as the patient experienced clinical progression prior to starting therapy. This patient is excluded from the adverse event reporting.
 
Arm/Group Title Medulloblastoma: Lapatinib Prior to Surgery Medulloblastoma: No Lapatinib Prior to Surgery Medulloblastoma: No Surgery High Grade Glioma: No Surgery Ependymoma: Lapatinib Prior to Surgery Ependymoma: No Lapatnib Prior to Surgery Ependymoma: No Surgery
Hide Arm/Group Description Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery. Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment. Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment. Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment and were not eligible for the randomization to receive lapatinib or not prior to surgery.
All-Cause Mortality
Medulloblastoma: Lapatinib Prior to Surgery Medulloblastoma: No Lapatinib Prior to Surgery Medulloblastoma: No Surgery High Grade Glioma: No Surgery Ependymoma: Lapatinib Prior to Surgery Ependymoma: No Lapatnib Prior to Surgery Ependymoma: No Surgery
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Medulloblastoma: Lapatinib Prior to Surgery Medulloblastoma: No Lapatinib Prior to Surgery Medulloblastoma: No Surgery High Grade Glioma: No Surgery Ependymoma: Lapatinib Prior to Surgery Ependymoma: No Lapatnib Prior to Surgery Ependymoma: No Surgery
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/2 (100.00%)   1/2 (50.00%)   9/16 (56.25%)   10/13 (76.92%)   2/2 (100.00%)   1/2 (50.00%)   6/14 (42.86%) 
Gastrointestinal disorders               
Diarrhea  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/14 (0.00%) 
Vomiting  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/14 (0.00%) 
General disorders               
Fever (in the absence of neutropenia)  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/14 (0.00%) 
Investigations               
ALT, SGPT (serum glutamic pyruvic transaminase)  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/14 (0.00%) 
AST,SGOT (serum glutamic oxaloacetic transaminase)  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/14 (0.00%) 
Bilirubin (hyperbilirubinemia)  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  1/14 (7.14%) 
Leukocytes  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Lymphopenia  1  0/2 (0.00%)  0/2 (0.00%)  3/16 (18.75%)  3/13 (23.08%)  0/2 (0.00%)  0/2 (0.00%)  1/14 (7.14%) 
Neutrophils/granulocytes  1  0/2 (0.00%)  1/2 (50.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Platelets  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Metabolism and nutrition disorders               
Albumin, serum-low (hypoalbuminemia)  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  2/14 (14.29%) 
Calcium, serum-low (hypocalcemia)  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Dehydration  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/14 (0.00%) 
Phosphate, serum-low (hypophosphatemia)  1  1/2 (50.00%)  0/2 (0.00%)  3/16 (18.75%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  1/14 (7.14%) 
Potassium, serum-low (hypokalemia)  1  1/2 (50.00%)  0/2 (0.00%)  1/16 (6.25%)  0/13 (0.00%)  1/2 (50.00%)  1/2 (50.00%)  2/14 (14.29%) 
Sodium, serum-low (hyponatremia)  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/13 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  2/14 (14.29%) 
Nervous system disorders               
Ataxia (incoordination)  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  2/13 (15.38%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Leak, cerebrospinal fluid  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/14 (0.00%) 
Seizure  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Somnolence/depressed level of consciousness  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Speech impairment  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Tremor  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Aspiration  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/14 (7.14%) 
Hypoxia  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/14 (7.14%) 
Vascular disorders               
Hypertension  1  0/2 (0.00%)  0/2 (0.00%)  2/16 (12.50%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Medulloblastoma: Lapatinib Prior to Surgery Medulloblastoma: No Lapatinib Prior to Surgery Medulloblastoma: No Surgery High Grade Glioma: No Surgery Ependymoma: Lapatinib Prior to Surgery Ependymoma: No Lapatnib Prior to Surgery Ependymoma: No Surgery
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/2 (100.00%)   2/2 (100.00%)   16/16 (100.00%)   13/13 (100.00%)   2/2 (100.00%)   2/2 (100.00%)   14/14 (100.00%) 
Endocrine disorders               
Cushingoid appearance  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/13 (7.69%)  1/2 (50.00%)  0/2 (0.00%)  0/14 (0.00%) 
Eye disorders               
Ophthalmoplegia/diplopia (double vision)  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  1/2 (50.00%)  0/14 (0.00%) 
Vision-photophobia  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Gastrointestinal disorders               
Constipation  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  2/14 (14.29%) 
Diarrhea  1  2/2 (100.00%)  2/2 (100.00%)  13/16 (81.25%)  7/13 (53.85%)  2/2 (100.00%)  1/2 (50.00%)  12/14 (85.71%) 
Dysphagia  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Enteritis  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/14 (7.14%) 
Flatulence  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Gastritis  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Heartburn/dyspepsia  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Incontinence, anal  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  2/14 (14.29%) 
Nausea  1  0/2 (0.00%)  0/2 (0.00%)  3/16 (18.75%)  0/13 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  5/14 (35.71%) 
Vomiting  1  1/2 (50.00%)  0/2 (0.00%)  9/16 (56.25%)  4/13 (30.77%)  0/2 (0.00%)  1/2 (50.00%)  7/14 (50.00%) 
General disorders               
Fever (in the absence of neutropenia)  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/13 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  5/14 (35.71%) 
Irritability (children < 3 years of age)  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/14 (7.14%) 
Extremity-lower (gait/walking)  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  2/14 (14.29%) 
Investigations               
ALT, SGPT (serum glutamic pyruvic transaminase)  1  0/2 (0.00%)  1/2 (50.00%)  4/16 (25.00%)  4/13 (30.77%)  0/2 (0.00%)  1/2 (50.00%)  7/14 (50.00%) 
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  0/2 (0.00%)  2/2 (100.00%)  1/16 (6.25%)  4/13 (30.77%)  0/2 (0.00%)  0/2 (0.00%)  5/14 (35.71%) 
Alkaline phosphatase  1  0/2 (0.00%)  1/2 (50.00%)  0/16 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  1/2 (50.00%)  1/14 (7.14%) 
Amylase  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/14 (0.00%) 
Bilirubin (hyperbilirubinemia)  1  0/2 (0.00%)  1/2 (50.00%)  4/16 (25.00%)  2/13 (15.38%)  2/2 (100.00%)  0/2 (0.00%)  4/14 (28.57%) 
Cholesterol, serum-high (hypercholesteremia)  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Creatinine  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  2/13 (15.38%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
GGT (gamma-Glutamyl transpeptidase)  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  1/2 (50.00%)  0/14 (0.00%) 
Leukocytes  1  0/2 (0.00%)  2/2 (100.00%)  5/16 (31.25%)  1/13 (7.69%)  2/2 (100.00%)  0/2 (0.00%)  1/14 (7.14%) 
Lymphopenia  1  1/2 (50.00%)  0/2 (0.00%)  7/16 (43.75%)  5/13 (38.46%)  1/2 (50.00%)  1/2 (50.00%)  2/14 (14.29%) 
Neutrophils/granulocytes  1  0/2 (0.00%)  1/2 (50.00%)  0/16 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  1/14 (7.14%) 
Platelets  1  0/2 (0.00%)  0/2 (0.00%)  2/16 (12.50%)  0/13 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/14 (0.00%) 
Weight loss  1  0/2 (0.00%)  2/2 (100.00%)  2/16 (12.50%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Metabolism and nutrition disorders               
Albumin, serum-low (hypoalbuminemia)  1  1/2 (50.00%)  0/2 (0.00%)  1/16 (6.25%)  3/13 (23.08%)  0/2 (0.00%)  1/2 (50.00%)  4/14 (28.57%) 
Anorexia  1  1/2 (50.00%)  2/2 (100.00%)  4/16 (25.00%)  2/13 (15.38%)  1/2 (50.00%)  1/2 (50.00%)  1/14 (7.14%) 
Bicarbonate, serum-low  1  0/2 (0.00%)  0/2 (0.00%)  2/16 (12.50%)  1/13 (7.69%)  1/2 (50.00%)  1/2 (50.00%)  4/14 (28.57%) 
Calcium, serum-high (hypercalcemia)  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Calcium, serum-low (hypocalcemia)  1  0/2 (0.00%)  0/2 (0.00%)  4/16 (25.00%)  3/13 (23.08%)  1/2 (50.00%)  1/2 (50.00%)  2/14 (14.29%) 
Dehydration  1  1/2 (50.00%)  0/2 (0.00%)  3/16 (18.75%)  0/13 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  2/14 (14.29%) 
Glucose, serum-high (hyperglycemia)  1  0/2 (0.00%)  0/2 (0.00%)  2/16 (12.50%)  3/13 (23.08%)  1/2 (50.00%)  1/2 (50.00%)  5/14 (35.71%) 
Glucose, serum-low (hypoglycemia)  1  0/2 (0.00%)  0/2 (0.00%)  4/16 (25.00%)  0/13 (0.00%)  1/2 (50.00%)  1/2 (50.00%)  2/14 (14.29%) 
Magnesium, serum-high (hypermagnesemia)  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  3/13 (23.08%)  1/2 (50.00%)  0/2 (0.00%)  0/14 (0.00%) 
Magnesium, serum-low (hypomagnesemia)  1  0/2 (0.00%)  0/2 (0.00%)  3/16 (18.75%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/14 (7.14%) 
Phosphate, serum-low (hypophosphatemia)  1  0/2 (0.00%)  1/2 (50.00%)  4/16 (25.00%)  3/13 (23.08%)  1/2 (50.00%)  1/2 (50.00%)  6/14 (42.86%) 
Potassium, serum-high (hyperkalemia)  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  2/14 (14.29%) 
Potassium, serum-low (hypokalemia)  1  0/2 (0.00%)  0/2 (0.00%)  4/16 (25.00%)  5/13 (38.46%)  2/2 (100.00%)  0/2 (0.00%)  4/14 (28.57%) 
Sodium, serum-high (hypernatremia)  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Sodium, serum-low (hyponatremia)  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  2/13 (15.38%)  1/2 (50.00%)  0/2 (0.00%)  2/14 (14.29%) 
Triglyceride, serum-high (hypertriglyceridemia)  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders               
Extremity-upper (function)  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Nervous system disorders               
Ataxia  1  0/2 (0.00%)  0/2 (0.00%)  2/16 (12.50%)  2/13 (15.38%)  0/2 (0.00%)  0/2 (0.00%)  2/14 (14.29%) 
Dizziness  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  2/13 (15.38%)  0/2 (0.00%)  1/2 (50.00%)  0/14 (0.00%) 
Hydrocephalus  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Leak, cerebrospinal fluid  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/14 (0.00%) 
Nystagmus  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Seizure  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  1/13 (7.69%)  1/2 (50.00%)  0/2 (0.00%)  0/14 (0.00%) 
Somnolence/depressed level of consciousness  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Speech impairment  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Tremor  1  0/2 (0.00%)  0/2 (0.00%)  2/16 (12.50%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Psychiatric disorders               
Confusion  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Insomnia  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Personality/behavioral  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Renal and urinary disorders               
Cystitis  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/14 (0.00%) 
Incontinence, urinary  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  3/13 (23.08%)  0/2 (0.00%)  0/2 (0.00%)  1/14 (7.14%) 
Proteinuria  1  0/2 (0.00%)  1/2 (50.00%)  0/16 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  1/14 (7.14%) 
Urinary frequency/urgency  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Urine color change  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/14 (7.14%) 
Respiratory, thoracic and mediastinal disorders               
Allergic rhinitis  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  1/2 (50.00%)  1/2 (50.00%)  1/14 (7.14%) 
Cough  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  1/2 (50.00%)  1/2 (50.00%)  3/14 (21.43%) 
Pneumonitis/pulmonary infiltrates  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/14 (7.14%) 
Voice changes/dysarthria  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/14 (7.14%) 
Skin and subcutaneous tissue disorders               
Dry skin  1  0/2 (0.00%)  0/2 (0.00%)  3/16 (18.75%)  1/13 (7.69%)  0/2 (0.00%)  1/2 (50.00%)  1/14 (7.14%) 
Hair loss/alopecia  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  1/14 (7.14%) 
Nail changes  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/14 (7.14%) 
Pruritus/itching  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Rash/desquamation  1  0/2 (0.00%)  2/2 (100.00%)  3/16 (18.75%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  7/14 (50.00%) 
Rash: acne/acneiform  1  0/2 (0.00%)  0/2 (0.00%)  3/16 (18.75%)  2/13 (15.38%)  0/2 (0.00%)  0/2 (0.00%)  1/14 (7.14%) 
Rash: hand-foot skin reaction  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Sweating (diaphoresis)  1  0/2 (0.00%)  0/2 (0.00%)  1/16 (6.25%)  0/13 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Vascular disorders               
Flushing  1  0/2 (0.00%)  0/2 (0.00%)  0/16 (0.00%)  1/13 (7.69%)  0/2 (0.00%)  0/2 (0.00%)  0/14 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Accrual to the Molecular Biology phase (MBP) was contingent upon accrual being open for the Phase II since some participants in the MBP could be counted in the phase II. The phase II enrolled rapidly thus limiting enrollment to the MBP.
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: Assistant Director Operations and Biostatistics Center
Organization: Pediatric Brain Tumor Consortium
Phone: 901-595-2617
EMail: dana.wallace@stjude.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00095940    
Other Study ID Numbers: NCI-2012-03007
NCI-2012-03007 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PBTC-016 ( Other Identifier: Pediatric Brain Tumor Consortium )
PBTC-016 ( Other Identifier: CTEP )
U01CA081457 ( U.S. NIH Grant/Contract )
First Submitted: November 9, 2004
First Posted: November 9, 2004
Results First Submitted: August 2, 2011
Results First Posted: February 6, 2012
Last Update Posted: May 23, 2014