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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00633087
Recruitment Status : Terminated (Slow accrual)
First Posted : March 11, 2008
Results First Posted : January 7, 2014
Last Update Posted : January 7, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: 2-deoxyglucose

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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

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
No text entered.


  More Information

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



Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00633087     History of Changes
Other Study ID Numbers: 080402
IRB# 0220044763 ( Other Identifier: IRB )
First Submitted: March 3, 2008
First Posted: March 11, 2008
Results First Submitted: November 15, 2013
Results First Posted: January 7, 2014
Last Update Posted: January 7, 2014