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Erlotinib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Glioma

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ClinicalTrials.gov Identifier: NCT00124657
Recruitment Status : Completed
First Posted : July 28, 2005
Results First Posted : April 29, 2014
Last Update Posted : December 4, 2015
Sponsor:
Collaborators:
Rady Children's Hospital, San Diego
Duke University
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Brain and Central Nervous System Tumors
Intervention: Drug: Erlotinib hydrochloride

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Overall accrual included 62 unique subjects. Five subjects participated in both Phase I and Phase II. Phase I enrolled 23 (03/2005-06/2007). Phase II enrolled an additional 39 participants (08/2007-11/2010) plus 5 carried over from Phase I for a total of 44. One of the 39 accrued to Phase II was enrolled at Rady Children's Hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants had newly diagnosed high-grade glioma (except those originating in the brain stem) and unfavorable low-grade glioma and were ≥ 3 and ≤21 years of age. Participants receiving enzyme-inducing anticonvulsants (EIACs) were not eligible for this study. Patients with spinal cord tumors were eligible for the Phase II component of this study.

Reporting Groups
  Description
Phase I Only 18 participants were enrolled on the Phase I portion of the trial only.
Phase I and Phase II 5 patients participated in both the Phase I portion and the Phase II portion of the study.
Phase II Only 39 participants were enrolled on the Phase II portion of the trial only.

Participant Flow:   Overall Study
    Phase I Only   Phase I and Phase II   Phase II Only
STARTED   18   5   39 
COMPLETED   2   0   7 
NOT COMPLETED   16   5   32 
Toxicity                0                0                1 
Non-compliance                1                0                4 
Progressive disease                14                5                27 
Intercurrent illness                1                0                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Phase I Only 18 participants were enrolled on the Phase I portion of the trial only.
Phase I and Phase II 5 patients participated in both the Phase I portion and the Phase II portion of the study.
Phase II Only 39 participants were enrolled on the Phase II portion of the trial only.
Total Total of all reporting groups

Baseline Measures
   Phase I Only   Phase I and Phase II   Phase II Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   5   39   62 
Age 
[Units: Years]
Mean (Standard Deviation)
 11.49  (4.31)   11.47  (6.05)   10.55  (4.85)   11.12  (4.81) 
Gender 
[Units: Participants]
       
Female   8   2   23   33 
Male   10   3   16   29 
Diagnosis 
[Units: Participants]
       
Anaplastic astrocytoma (AA)   7   1   19   27 
Glioblastoma multiforme (GBM)   8   4   17   29 
Anaplastic oligoastrocytoma   2   0   1   3 
Anaplastic ganglioglioma   1   0   0   1 
Unfavorable fibrillary astrocytoma   0   0   1   1 
Spinal GBM   0   0   1   1 


  Outcome Measures

1.  Primary:   Number of Participants With Dose-limiting Toxicity (DLT)   [ Time Frame: During the first 8 weeks of therapy ]

2.  Primary:   Maximum Tolerated Dose (MTD) of Erlotinib   [ Time Frame: During the first 8 weeks of therapy. ]

3.  Primary:   Progression Free Survival (PFS)   [ Time Frame: 1 and 2 years after end of therapy ]

4.  Secondary:   Cmax of Erlotinib and Its Metabolite OSI-420   [ Time Frame: After first dose of therapy, and Day 8 of therapy ]

5.  Secondary:   Erlotinib Tmax   [ Time Frame: After first dose of therapy ]

6.  Secondary:   AUC Time 0-infinite (AUCinf) of Erlotinib and Its Metabolite OSI-420   [ Time Frame: After first dose of therapy, and Day 8 of therapy ]

7.  Secondary:   Number of Positive Mutations of EGFR and Downstream Pathways   [ Time Frame: Once at tumor resection and diagnosis ]

8.  Secondary:   Ability of Erlotinib to Inhibit EGFR Signaling   [ Time Frame: 5 Years ]

9.  Secondary:   Correlation Between Standard Magnetic Resonance Imaging and Investigational Radiologic Techniques in Assessing Tumor Response to This Treatment   [ Time Frame: at diagnosis and regular intervals during therapy (up to 2 years after start of therapy) ]

10.  Secondary:   To Prospectively Investigate the Technical Factors Involved in Planning and Administering Conformal Fractionated RT as Outlined in This Study, and to Correlate RT Dosimetry With Patterns of Failure, Standard and Investigational Imaging and Toxicity   [ Time Frame: 5 Years ]

11.  Secondary:   Plasma and CSF Levels of VEGF, bFGF, and SDF1   [ Time Frame: at diagnosis and regular intervals during therapy (up to 2 years after start of therapy) ]

12.  Secondary:   Number of Participants Experiencing Grade 3 or 4 Toxicity Events   [ Time Frame: From start of therapy through 2 years. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alberto Broniscer, MD
Organization: St. Jude Children's Research Hospital
phone: 866-966-5934
e-mail: info@stjude.org



Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00124657     History of Changes
Other Study ID Numbers: SJHG04
First Submitted: July 26, 2005
First Posted: July 28, 2005
Results First Submitted: September 10, 2013
Results First Posted: April 29, 2014
Last Update Posted: December 4, 2015