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Dichloroacetate (DCA) in Patients With Previously Treated Metastatic Breast or Non-Small Cell Lung Cancer (NSCL)

This study has been terminated.
(DSMB determined, due to higher than expected risk/safety concerns, study should be closed.)
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01029925
First received: December 9, 2009
Last updated: January 14, 2016
Last verified: June 2013
Results First Received: April 2, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Metastatic Breast Cancer
Lung Cancer
Intervention: Drug: Dichloroacetate (DCA)

  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
Patients with breast cancer (1) and non-small cell lung cancer (6) were recruited at UCLA between January 2010 and December 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient developed a brain metastasis before beginning therapy and had to be excluded, and two patients were undergoing screening procedures when the study was placed on voluntary hold.

Reporting Groups
  Description
Dichloroacetate (DCA) Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.

Participant Flow for 2 periods

Period 1:   Completion of Cycle 1 (28 Days)
    Dichloroacetate (DCA)  
STARTED     7  
COMPLETED     3  
NOT COMPLETED     4  
Death                 2  
Withdrawal by Subject                 2  

Period 2:   Completion of Cycle 2 (56 Days)
    Dichloroacetate (DCA)  
STARTED     3  
COMPLETED     2  
NOT COMPLETED     1  
off study due to disease progression                 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.
Stage 1 has best prognosis and stage IV has worst.Grade 1 is associated with best prognosis and grade 3 with poor prognosis.ECOG performance status grades a person's overall well-being and scaled from 0-5.ECOG of 0 is associated with best prognosis.Patients with ECOG 0-2 are considered well enough to receive additional treatments for their cancer.

Reporting Groups
  Description
Dichloroacetate (DCA) Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.

Baseline Measures
    Dichloroacetate (DCA)  
Number of Participants  
[units: participants]
  7  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     3  
Gender  
[units: participants]
 
Female     4  
Male     3  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     2  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     5  
More than one race     0  
Unknown or Not Reported     0  
stage at diagnosis  
[units: participants]
 
Stage II breast cancer     1  
Stage IV NSCLC     6  
ECOG status  
[units: participants]
 
ECOG status 0     2  
ECOG status 1     3  
ECOG status 2     2  



  Outcome Measures

1.  Primary:   Response Rate by RECIST Criteria of Oral Dichloroacetate in Patients With Recurrent and/or Metastatic and Pretreated Breast and Non-small Cell Lung Cancer.   [ Time Frame: upto 72 days ]


  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
The greatest limitation in our study was early termination due to perceived lack of drug efficacy leading to small number of subjects analyzed.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Edward Garon, MD
Organization: University of California Los Angeles Jonsson Comprehensive Cancer Center
phone: 310 586 2098
e-mail: egaron@mednet.ucla.edu


Publications:
Warburg O. Ueber den stoffweschsel der tumoren (London: Constable). (1930).

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01029925     History of Changes
Other Study ID Numbers: DCA Breast NSCLC
09-07-013 ( Other Identifier: UCLA IRB )
Study First Received: December 9, 2009
Results First Received: April 2, 2013
Last Updated: January 14, 2016
Health Authority: United States: Food and Drug Administration