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Mouse Cancer Cell-containing Macrobeads in the Treatment of Human Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Rogosin Institute
ClinicalTrials.gov Identifier:
NCT00283075
First received: January 26, 2006
Last updated: February 11, 2016
Last verified: February 2016
Results First Received: October 26, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Intraabdominal Cancers (Various Types)
Intervention: Biological: Cancer Macrobead placement in abdominal cavity

  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
Fifty-six subjects provided informed consent to participate in this study; of these 31 subjects underwent the implantation of macrobeads that contain mouse renal adenocarcinoma cells (RENCA macrobeads). The first subject was implanted on 6 April 2005 and the last subject was implanted on 1 November 2011.

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
8 RENCA Macrobeads/kg Body Weight Implantation RENCA macrobeads placement in abdominal cavity at 8 RENCA macrobeads/kg body weight.
16 RENCA Macrobeads/kg Body Weight Implantation RENCA macrobeads placement in abdominal cavity at 16 RENCA macrobeads/kg body weight.

Participant Flow:   Overall Study
    8 RENCA Macrobeads/kg Body Weight Implantation   16 RENCA Macrobeads/kg Body Weight Implantation
STARTED   25   6 
COMPLETED   25   6 
NOT COMPLETED   0   0 



  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
All Participants All participants who had at least one implantation of RENCA macrobeads, either at 8 RENCA macrobeads/kg body weight or 16 RENCA macrobeads/kg body weight.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 31 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.1  (8.53) 
Gender 
[Units: Participants]
 
Female   16 
Male   15 
Race/Ethnicity, Customized 
[Units: Participants]
 
White   12 
Hispanic   2 
Asian   1 
Not Available   16 


  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose (MTD) of RENCA Macrobeads   [ Time Frame: 6 months ]

2.  Primary:   Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)   [ Time Frame: 6 months ]

3.  Secondary:   Overall Survival   [ Time Frame: From date of RENCA macrobeads implantation until date of death from any cause ]

4.  Other Pre-specified:   Tumor Marker Response   [ Time Frame: Prior to Implantation and Day 7, Day 14, Day 21 and Day 28 after each implantation ]


  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: Dr. Barry H. Smith, CEO
Organization: The Rogosin Institute
phone: 212-746-1551
e-mail: bas2005@nyp.org


Publications:


Responsible Party: The Rogosin Institute
ClinicalTrials.gov Identifier: NCT00283075     History of Changes
Other Study ID Numbers: 0407007343
Study First Received: January 26, 2006
Results First Received: October 26, 2015
Last Updated: February 11, 2016
Health Authority: United States: Food and Drug Administration