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

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. Identifier: NCT01029925
Recruitment Status : Terminated (DSMB determined, due to higher than expected risk/safety concerns, study should be closed.)
First Posted : December 10, 2009
Results First Posted : February 12, 2016
Last Update Posted : February 12, 2016
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Metastatic Breast Cancer
Lung Cancer
Intervention: Drug: Dichloroacetate (DCA)

  Participant Flow

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
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)
Death                2 
Withdrawal by Subject                2 

Period 2:   Completion of Cycle 2 (56 Days)
    Dichloroacetate (DCA)
off study due to disease progression                1 

  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.
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
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) 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   4 
>=65 years   3 
[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

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

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

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

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

Responsible Party: Jonsson Comprehensive Cancer Center Identifier: NCT01029925     History of Changes
Other Study ID Numbers: DCA Breast NSCLC
09-07-013 ( Other Identifier: UCLA IRB )
First Submitted: December 9, 2009
First Posted: December 10, 2009
Results First Submitted: April 2, 2013
Results First Posted: February 12, 2016
Last Update Posted: February 12, 2016