Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
United States Department of Defense
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: 2-deoxyglucose
Enrollment 12
Recruitment Details Twelve subjects were enrolled from April 2007 through June 2009 at The Cancer Institute of New Jersey, a comprehensive cancer center.
Pre-assignment Details  
Arm/Group Title 2-deoxyglucose
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title 2-deoxyglucose
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  25.0%
>=65 years
9
  75.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants
65.3  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
1
   8.3%
Male
11
  91.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants
12
1.Primary Outcome
Title To Determine the Biochemical Response of This Regimen in Patients With HRPC
Hide Description A PSA response is defined as a PSA decrease of 50% from baseline maintained for at least 28 days.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.
Arm/Group Title 2-deoxyglucose
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Duration of Response
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.
Arm/Group Title 2-deoxyglucose
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Progression-free Survival
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.
Arm/Group Title 2-deoxyglucose
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was closed early due to slow accrual and insufficient data were collected to assess this outcome measure.
Arm/Group Title 2-deoxyglucose
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2-deoxyglucose
Hide Arm/Group Description 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.
All-Cause Mortality
2-deoxyglucose
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
2-deoxyglucose
Affected / at Risk (%) # Events
Total   3/12 (25.00%)    
General disorders   
Pain - Back * 1  1/12 (8.33%)  1
Fatigue (asthenia, lethargy, malaise) * 1  1/12 (8.33%)  1
Pain (right lower quadrant) * 1  1/12 (8.33%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
2-deoxyglucose
Affected / at Risk (%) # Events
Total   10/12 (83.33%)    
Blood and lymphatic system disorders   
Platelets * 1  1/12 (8.33%)  2
Edema: limb * 1  1/12 (8.33%)  1
Cardiac disorders   
Prolonged QTc interval * 1  4/12 (33.33%)  4
Conduction abnormality/atrioventricular heart block * 1  1/12 (8.33%)  3
Gastrointestinal disorders   
Constipation * 1  1/12 (8.33%)  1
Gastrointestinal - Other * 1  1/12 (8.33%)  1
General disorders   
Fatigue (asthenia, lethargy, malaise) * 1  5/12 (41.67%)  8
Pain * 1  2/12 (16.67%)  2
Pain - Back * 1  1/12 (8.33%)  2
Pain - Chest wall * 1  1/12 (8.33%)  1
Pain - Pelvis * 1  1/12 (8.33%)  1
Investigations   
Alkaline phosphatase * 1  1/12 (8.33%)  1
Respiratory, thoracic and mediastinal disorders   
Hemorrhage, pulmonary/upper respiratory (nose) * 1  1/12 (8.33%)  1
Dyspnea (shortness of breath) * 1  1/12 (8.33%)  1
Skin and subcutaneous tissue disorders   
Rash: acne/acneiform * 1  1/12 (8.33%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robert DiPaola, MD
Organization: Rutgers Cancer Institute of New Jersey
Phone: 732-235-8675
EMail: dipaolrs@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu
Layout table for additonal information
Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00633087    
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