This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

A Phase II Trial of Valproic Acid in Patients With Advanced Thyroid Cancers of Follicular Cell Origin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Electron Kebebew, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01182285
First received: August 13, 2010
Last updated: October 20, 2016
Last verified: October 2016
Results First Received: August 22, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Thyroid Neoplasm
Interventions: Drug: Valproic Acid
Drug: Liothyronine Sodium

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Five and eight participants were enrolled from University of California San Francisco (UCSF) and the National Institutes of Health (NIH), respectively.

Reporting Groups
  Description
A - Phase 1 Radioiodine Resistant Thyroid Cancer Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
B1 - Phase 2 Schedule 1 (Increased Radioiodine Uptake) Drug: Valproic Acid Week 11 - 17 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Drug: Cytomel (25 micrograms) Patients who exhibit an increased radioiodine uptake on Thyrogen scan post valproic acid therapy at week 10. Begin Liothyronine Sodium (Cytomel) for 4 weeks (25 micrograms twice a day)
B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake) Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.

Participant Flow for 3 periods

Period 1:   First Intervention Week 1-10
    A - Phase 1 Radioiodine Resistant Thyroid Cancer   B1 - Phase 2 Schedule 1 (Increased Radioiodine Uptake)   B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)
STARTED   13   0   0 
COMPLETED   10   0   0 
NOT COMPLETED   3   0   0 
Disease progression                1                0                0 
Adverse Event                1                0                0 
Non-compliance                1                0                0 

Period 2:   Second Intervention Week 11-17
    A - Phase 1 Radioiodine Resistant Thyroid Cancer   B1 - Phase 2 Schedule 1 (Increased Radioiodine Uptake)   B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)
STARTED   0   0   0 
COMPLETED   0   0   0 
NOT COMPLETED   0   0   0 

Period 3:   Third Intervention Week 11-52
    A - Phase 1 Radioiodine Resistant Thyroid Cancer   B1 - Phase 2 Schedule 1 (Increased Radioiodine Uptake)   B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)
STARTED   0   0   8 [1] 
COMPLETED   0   0   0 
NOT COMPLETED   0   0   8 
Disease Progression                0                0                6 
Other                0                0                2 
[1] 2 subj. taken off study after completing ph 1: 1 due to a negative uptake scan & one off due to PD.



  Baseline Characteristics
  Hide 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.
Five and eight participants were enrolled from University of California San Francisco (UCSF), and the National Institutes of Health, respectively.

Reporting Groups
  Description
All Participants (Phase 1 and Phase 2 Schedule 2)

A- Phase 1 Radioiodine-Resistant Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening

B2 - Phase 2 Schedule 2 Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.


Baseline Measures
   All Participants (Phase 1 and Phase 2 Schedule 2) 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   9 
>=65 years   4 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.08  (7.63) 
Gender 
[Units: Participants]
 
Female   4 
Male   9 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   0 
Not Hispanic or Latino   11 
Unknown or Not Reported   2 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   2 
White   9 
More than one race   0 
Unknown or Not Reported   2 
Region of Enrollment 
[Units: Participants]
 
United States   13 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   RAI (Radioactive Iodine) Uptake and Tg (Thyroglobulin) Level Compared Pre and Post- Valproic Treatment   [ Time Frame: Entry to study and after 10 weeks of treatment for Phase 1, and 10 weeks of treatment to 16 weeks of treatment for phase 2. ]

2.  Primary:   Number of Participants With Adverse Events   [ Time Frame: 41 months and 11 days ]

3.  Secondary:   Best Overall Response   [ Time Frame: Week 16 ]

4.  Secondary:   NIS (Na/I-symporter) Expression   [ Time Frame: Entry to study and after 10 weeks of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide 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: Dr. Electron Kebebew
Organization: National Cancer Institute
phone: 301-496-5049
e-mail: kebebew@nih.gov


Publications of Results:
Other Publications:

Responsible Party: Electron Kebebew, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01182285     History of Changes
Other Study ID Numbers: 100041
10-C-0041
Study First Received: August 13, 2010
Results First Received: August 22, 2016
Last Updated: October 20, 2016