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Tanespimycin in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer

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ClinicalTrials.gov Identifier: NCT00118248
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : May 6, 2014
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Recurrent Thyroid Cancer
Stage IV Follicular Thyroid Cancer
Stage IV Papillary Thyroid Cancer
Thyroid Gland Medullary Carcinoma
Intervention: Drug: tanespimycin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

From February 2005 thru April 2009, 41 participants were accrued to the this study.

The study was closed to enrollment in July, 2009 due to a slow accrual rate.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
From February 2005 thru February 2009, 17 participants were accrued to the Advanced Medullary Thyroid Carcinoma group. From February 2008 thru April 2009, 24 participants were accrued to the Differentiated Thyroid Carcinoma group.

Reporting Groups
  Description
Advanced Medullary Thyroid Carcinoma Group Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Differentiated Thyroid Carcinoma Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Advanced Medullary Thyroid Carcinoma Group   Differentiated Thyroid Carcinoma
STARTED   17   24 
COMPLETED   17   24 
NOT COMPLETED   0   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
Advanced Medullary Thyroid Carcinoma Group Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Differentiated Thyroid Carcinoma Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
   Advanced Medullary Thyroid Carcinoma Group   Differentiated Thyroid Carcinoma   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   24   41 
Age 
[Units: Years]
Median (Full Range)
 56 
 (33 to 70) 
 61 
 (34 to 80) 
 60 
 (33 to 80) 
Gender 
[Units: Participants]
Count of Participants
     
Female      5  29.4%      11  45.8%      16  39.0% 
Male      12  70.6%      13  54.2%      25  61.0% 
Region of Enrollment 
[Units: Participants]
     
United States   17   24   41 


  Outcome Measures

1.  Primary:   Proportion of Patients Who Have Remained on Treatment and Progression-free at Least One Year After Start of 17-AAG (Tanespimycin)   [ Time Frame: 1 year ]

2.  Secondary:   Overall Response   [ Time Frame: Baseline, every 3 courses, and at the end of treatment study ]

3.  Secondary:   Progression-Free Survival   [ Time Frame: Every 3 months for up to 3 years ]

4.  Secondary:   Overall Survival   [ Time Frame: Every 3 months until progression, and then every 6 months up to 3 years ]

5.  Secondary:   Toxicity   [ Time Frame: Every 3 courses during treatment (median cycle number was 5 with a maximum of 38 cycles) ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jeffrey F. Moley, M.D.
Organization: Washington University School of Medicine
e-mail: moleyj@wustl.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00118248     History of Changes
Obsolete Identifiers: NCT01646944, NCT01664351
Other Study ID Numbers: NCI-2009-00063
NCI-2009-00063 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
JHOC-B/06/174
NCI-6482
JHOC-JS0652
CDR0000433150
MC0476 ( Other Identifier: Mayo Clinic )
6482 ( Other Identifier: CTEP )
N01CM62205 ( U.S. NIH Grant/Contract )
P30CA015083 ( U.S. NIH Grant/Contract )
N01CM62207 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2005
First Posted: July 11, 2005
Results First Submitted: September 20, 2013
Results First Posted: May 6, 2014
Last Update Posted: February 15, 2017