A Phase I/II Trial of 2-Deoxyglucose (2DG) for the Treatment of Advanced Cancer and Hormone Refractory Prostate Cancer

This study has been terminated.
(Slow accrual)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00633087
First received: March 3, 2008
Last updated: November 15, 2013
Last verified: November 2013
Results First Received: November 15, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: 2-deoxyglucose

  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
Twelve subjects were enrolled from April 2007 through June 2009 at The Cancer Institute of New Jersey, a comprehensive cancer center.

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
2-deoxyglucose 2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.

Participant Flow:   Overall Study
    2-deoxyglucose  
STARTED     12  
COMPLETED     12  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
2-deoxyglucose 2-deoxyglucose : 30 mg/kg of 2-deoxyglucose administered orally on a daily schedule for two weeks (Days 1-14) of a three week (21 Day) cycle.

Baseline Measures
    2-deoxyglucose  
Number of Participants  
[units: participants]
  12  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     9  
Age  
[units: years]
Mean ± Standard Deviation
  65.3  ± 12.0  
Gender  
[units: participants]
 
Female     1  
Male     11  
Region of Enrollment  
[units: participants]
 
United States     12  



  Outcome Measures
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1.  Primary:   To Determine the Biochemical Response of This Regimen in Patients With HRPC   [ Time Frame: 5 years ]

2.  Secondary:   Duration of Response   [ Time Frame: 5 years ]

3.  Secondary:   Progression-free Survival   [ Time Frame: 5 years ]

4.  Secondary:   Overall Survival   [ Time Frame: 5 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: Dr. Robert DiPaola, MD
Organization: Rutgers Cancer Institute of New Jersey
phone: 732-235-8675
e-mail: dipaolrs@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu


No publications provided


Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00633087     History of Changes
Other Study ID Numbers: 080402, IRB# 0220044763
Study First Received: March 3, 2008
Results First Received: November 15, 2013
Last Updated: November 15, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board