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17-AAG in Treating Patients With Relapsed or Refractory Anaplastic Large Cell Lymphoma, Mantle Cell Lymphoma, or Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00117988
First received: July 8, 2005
Last updated: May 21, 2014
Last verified: February 2013
Results First Received: May 5, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Anaplastic Large Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Recurrent Mantle Cell Lymphoma
Intervention: Drug: tanespimycin

  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
Recruitment Period: 02/08/2005 through 05/08/2009. All participant recruitment attempted at UT MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
17-AAG 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days

Participant Flow:   Overall Study
    17-AAG  
STARTED     22  
COMPLETED     18  
NOT COMPLETED     4  
Death                 3  
Adverse Event                 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.
No text entered.

Reporting Groups
  Description
17-AAG 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days

Baseline Measures
    17-AAG  
Number of Participants  
[units: participants]
  22  
Age  
[units: years]
Median ( Full Range )
  49.5  
  ( 25 to 76 )  
Gender  
[units: participants]
 
Female     6  
Male     16  
Region of Enrollment  
[units: participants]
 
United States     22  



  Outcome Measures

1.  Primary:   Number of Patients With Response   [ Time Frame: Baseline to time to best response; Every 6 weeks ]


  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
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  More Information
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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: Dr. Anas Younes, MD / Professor
Organization: UT MD Anderson Cancer Center
e-mail: etubbs@mdanderson.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00117988     History of Changes
Other Study ID Numbers: NCI-2009-00101, NCI-2009-00101, CDR0000433593, 2004-0792, 6936, P30CA016672, R21CA117070
Study First Received: July 8, 2005
Results First Received: May 5, 2011
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration