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A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IRX Therapeutics
ClinicalTrials.gov Identifier:
NCT00210470
First received: September 13, 2005
Last updated: May 22, 2012
Last verified: May 2012
Results First Received: January 6, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Squamous Cell Carcinoma of the Head and Neck
Interventions: Biological: IRX-2
Drug: Cyclophosphamide
Drug: Indomethacin
Drug: Zinc
Drug: Omeprazole

  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
IRX-2 Regimen The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.

Participant Flow:   Overall Study
    IRX-2 Regimen  
STARTED     27  
COMPLETED     26  
NOT COMPLETED     1  
Subject did not continue to surgery                 1  



  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
IRX-2 Regimen The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.

Baseline Measures
    IRX-2 Regimen  
Number of Participants  
[units: participants]
  27  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     24  
>=65 years     3  
Age  
[units: years]
Mean ± Standard Deviation
  57.4  ± 9.4  
Gender  
[units: participants]
 
Female     7  
Male     20  
Region of Enrollment  
[units: participants]
 
United States     26  
Mexico     1  



  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events and Serious Adverse Events   [ Time Frame: Enrollment through 30 days post-surgery ]

2.  Secondary:   Clinical and Histological Tumor Responses   [ Time Frame: At approx. 21 days, prior to surgery ]
Results not yet reported.   Anticipated Reporting Date:   09/2012   Safety Issue:   No

3.  Secondary:   Evaluate Patient Tolerance of Surgery and Post-operative Adjuvant Therapy;   [ Time Frame: Following surgery and post-operative therapy ]
Results not yet reported.   Anticipated Reporting Date:   09/2012   Safety Issue:   No

4.  Secondary:   Immune Competence as Measured by Lymphocyte Infiltration   [ Time Frame: At approx. 21 days, prior to surgery ]
Results not yet reported.   Anticipated Reporting Date:   09/2012   Safety Issue:   No

5.  Secondary:   Disease-free Survival   [ Time Frame: Time from cyclophosphamide administration and time from surgery to death or confirmed recurrent or progressive disease ]
Results not yet reported.   Anticipated Reporting Date:   09/2012   Safety Issue:   No

6.  Secondary:   Overall Survival   [ Time Frame: Time from cyclophosphamide administration and time from surgery to death or confirmed recurrent or progressive disease ]
Results not yet reported.   Anticipated Reporting Date:   09/2012   Safety Issue:   No

7.  Secondary:   Correlation of Tumor Response or Immune Competence (Lymphocyte Infiltration) With Disease-Free Survival or Overall Survival   [ Time Frame: Time from cyclophosphamide administration and time from surgery to death or confirmed recurrent or progressive disease ]
Results not yet reported.   Anticipated Reporting Date:   09/2012   Safety Issue:   No


  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: Zygmund Roth, Ph.D., V.P., Regulatory Affairs and QA
Organization: IRX Therapeutics, Inc.
phone: 631-465-2028
e-mail: zroth@irxtherapeutics.com


Publications of Results:
Other Publications:


Responsible Party: IRX Therapeutics
ClinicalTrials.gov Identifier: NCT00210470     History of Changes
Other Study ID Numbers: IRX-2 2005-A
Study First Received: September 13, 2005
Results First Received: January 6, 2012
Last Updated: May 22, 2012
Health Authority: United States: Food and Drug Administration