Protracted Etoposide During Induction Therapy for High Risk Neuroblastoma (PEPI)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Texas Children's Hospital
Information provided by (Responsible Party):
Peter Zage, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00578864
First received: December 19, 2007
Last updated: March 5, 2014
Last verified: March 2014
Results First Received: October 5, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neuroblastoma
Interventions: Drug: Protracted Oral Etoposide
Drug: Adriamycin and Cyclophosphamide
Drug: IV Cisplatin and IV Bolus Etoposide

  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
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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
Phase II Window With Protracted Etoposide 2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
Phase II Window With Bolus Etoposide 2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide

Participant Flow:   Overall Study
    Phase II Window With Protracted Etoposide     Phase II Window With Bolus Etoposide  
STARTED     7     6  
COMPLETED     6 [1]   6  
NOT COMPLETED     1     0  
Death                 1                 0  
[1] died of complications of surgery after 2 cycles



  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.
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Reporting Groups
  Description
Phase II Window With Protracted Etoposide 2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
Phase II Window With Bolus Etoposide 2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
Total Total of all reporting groups

Baseline Measures
    Phase II Window With Protracted Etoposide     Phase II Window With Bolus Etoposide     Total  
Number of Participants  
[units: participants]
  7     6     13  
Age  
[units: month]
Median ( Full Range )
  26.9  
  ( 17.7 to 130.8 )  
  25.3  
  ( 8.4 to 34.3 )  
  26.9  
  ( 8.4 to 130.8 )  
Gender  
[units: participants]
     
Female     4     4     8  
Male     3     2     5  



  Outcome Measures
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1.  Primary:   Response Rate Associated With Two Cycles of Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma Tumors.   [ Time Frame: 2 months ]

2.  Primary:   Rate of Toxicities Associated With Cisplatin With Protracted Oral Etoposide When Administered as Up-front Window Therapy to Previously Untreated Children With High Risk Neuroblastoma.   [ Time Frame: 2 months ]

3.  Secondary:   Overall Survival in Children With High Risk Neuroblastoma Treated on This Regimen.   [ Time Frame: 3 years ]

4.  Secondary:   Percentage of Patients Who Have Surgery After the Second Cycle of Induction Therapy   [ Time Frame: 2 months ]

5.  Secondary:   Event Free Survival in Children With High Risk Neuroblastoma Treated on This Regimen.   [ Time Frame: 3 years ]


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


Results Point of Contact:  
Name/Title: Peter Zage, MD
Organization: BAYLOR
phone: 832-824-4615
e-mail: pezage@txch.org


No publications provided


Responsible Party: Peter Zage, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00578864     History of Changes
Obsolete Identifiers: NCT00600132
Other Study ID Numbers: H20255, PEPI
Study First Received: December 19, 2007
Results First Received: October 5, 2012
Last Updated: March 5, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration