Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00387790
First received: October 12, 2006
Last updated: May 7, 2014
Last verified: December 2012
Results First Received: December 18, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Untreated Childhood Brain Stem Glioma
Interventions: Drug: motexafin gadolinium
Radiation: 3-dimensional conformal radiation therapy

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Radiation and Motexafin Gadolinium

Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

motexafin gadolinium: Given IV

2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy


Participant Flow:   Overall Study
    Radiation and Motexafin Gadolinium
STARTED   64 
COMPLETED   50 
NOT COMPLETED   14 
Adverse Event                5 
Lack of Efficacy                2 
Physician Decision                2 
Withdrawal by Subject                3 
Ineligible for study                2 



  Baseline Characteristics
  Hide 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
Radiation and Motexafin Gadolinium

Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

motexafin gadolinium: Given IV

2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy


Baseline Measures
   Radiation and Motexafin Gadolinium 
Overall Participants Analyzed 
[Units: Participants]
 64 
Age [1] 
[Units: Years]
Mean (Full Range)
 6 
 (1 to 17) 
[1] Patients found not to meet the eligibility requirements are excluded from the age baseline measure.
Gender [1] 
[Units: Participants]
 
Female   34 
Male   30 
[1] Patients found not to meet the eligibility requirements were not included in the gender baseline measure.
Race (NIH/OMB) [1] 
[Units: Participants]
 
American Indian or Alaska Native   1 
Asian   1 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   11 
White   42 
More than one race   0 
Unknown or Not Reported   9 
[1] Patients found not to meet the eligibility requirements are excluded from the race baseline measure.
Ethnicity (NIH/OMB) [1] 
[Units: Participants]
 
Hispanic or Latino   7 
Not Hispanic or Latino   52 
Unknown or Not Reported   5 
[1] Patients found not to meet the eligibility requirements are excluded from the ethnicity baseline measure.
Region of Enrollment [1] 
[Units: Participants]
 
United States   55 
Canada   4 
Australia   5 
[1] Patients found not to meet the eligibility requirements are excluded from the region baseline measure.


  Outcome Measures

1.  Primary:   One Year Event-free Survival (EFS)   [ Time Frame: Time to disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, assessed up to 1 year after enrollment. ]

2.  Secondary:   One Year Overall Survival   [ Time Frame: Time to death from any cause, assessed up to 1 year after enrollment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Occurrence of Serious Toxicity   [ Time Frame: Up to 1 year after enrollment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 352-273-0558
e-mail: resultsreportingcoordinator@childrensoncologygroup.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00387790     History of Changes
Other Study ID Numbers: NCI-2012-01829
NCI-2012-01829 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000504107
COG-ACNS0222
ACNS0222 ( Other Identifier: Children's Oncology Group )
ACNS0222 ( Other Identifier: CTEP )
U10CA098543 ( US NIH Grant/Contract Award Number )
Study First Received: October 12, 2006
Results First Received: December 18, 2013
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration