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Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients With Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00653068
First received: April 3, 2008
Last updated: February 13, 2017
Last verified: February 2017
Results First Received: December 20, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Childhood Atypical Teratoid/Rhabdoid Tumor
Interventions: Procedure: autologous hematopoietic stem cell transplantation
Radiation: 3-dimensional conformal radiation therapy
Drug: methotrexate
Drug: leucovorin calcium
Drug: etoposide
Drug: cyclophosphamide
Drug: cisplatin
Biological: filgrastim
Drug: carboplatin
Drug: thiotepa
Drug: vincristine sulfate
Other: laboratory biomarker analysis

  Participant Flow
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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
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Reporting Groups
  Description
Treatment

Within 2-6 weeks after induction therapy or radiation therapy, patients receive high-dose carboplatin IV and high-dose thiotepa IV on days 1 and 2 and undergo autologous PBSC rescue on approximately day 4. Patients also receive G-CSF IV or SC once daily until ANC recovers.

Consolidation therapy followed by stem cell rescue repeats every 28 days for 3 courses (C) and 3D-CRT to the brain (and the spine if needed) 5 days a week for 5-6 weeks (R), the order of which depends on patient age, in the absence of disease progression or unacceptable toxicity.


Participant Flow:   Overall Study
    Treatment
STARTED   70 
COMPLETED   20 
NOT COMPLETED   50 
Death                9 
Lack of Efficacy                34 
Physician Decision                4 
Withdrawal by Subject                1 
Ineligible                2 



  Baseline Characteristics
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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
Stratum I Infants (<36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
Stratum II Infants with INI1 mutation only based diagnosis (histology is not consistent with AT/RT).
Stratum III Older children (greater than 36 months of age) with tumor histology and immunohistochemical analysis diagnostic of AT/RT.
Stratum IV Older children with INI1 mutation only based diagnosis.
Total Total of all reporting groups

Baseline Measures
   Stratum I   Stratum II   Stratum III   Stratum IV   Total 
Overall Participants Analyzed 
[Units: Participants]
 58   0   12   0   70 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      58 100.0%         12 100.0%         70 100.0% 
Between 18 and 65 years      0   0.0%         0   0.0%         0   0.0% 
>=65 years      0   0.0%         0   0.0%         0   0.0% 
Age 
[Units: Years]
Median (Full Range)
 1 
 (0 to 2) 
    4 
 (3 to 14) 
    1 
 (0 to 14) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      28  48.3%         8  66.7%         36  51.4% 
Male      30  51.7%         4  33.3%         34  48.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      15  25.9%         5  41.7%         20  28.6% 
Not Hispanic or Latino      39  67.2%         7  58.3%         46  65.7% 
Unknown or Not Reported      4   6.9%         0   0.0%         4   5.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      1   1.7%         0   0.0%         1   1.4% 
Asian      1   1.7%         2  16.7%         3   4.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%         0   0.0%         0   0.0% 
Black or African American      7  12.1%         1   8.3%         8  11.4% 
White      40  69.0%         7  58.3%         47  67.1% 
More than one race      0   0.0%         0   0.0%         0   0.0% 
Unknown or Not Reported      9  15.5%         2  16.7%         11  15.7% 
Region of Enrollment 
[Units: Participants]
Count of Participants
         
Canada   6      2      8 
United States   51      10      61 
Australia   1      0      1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Event-free Survival   [ Time Frame: Up to 4 years after study enrollment ]

2.  Primary:   Overall Survival (OS)   [ Time Frame: Up to 4 years after study enrollment ]

3.  Primary:   Toxic Death   [ Time Frame: During and after completion of study treatment up to 1 year after enrollment. ]

4.  Secondary:   Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy   [ Time Frame: During protocol therapy up to 1 year after enrollment. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org



Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00653068     History of Changes
Other Study ID Numbers: ACNS0333
NCI-2009-00337 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ACNS0333 ( Other Identifier: Children's Oncology Group )
ACNS0333 ( Other Identifier: Children's Oncology Group )
ACNS0333 ( Other Identifier: CTEP )
U10CA098543 ( U.S. NIH Grant/Contract )
Study First Received: April 3, 2008
Results First Received: December 20, 2016
Last Updated: February 13, 2017