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

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ClinicalTrials.gov Identifier: NCT00117988
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : May 30, 2011
Last Update Posted : May 30, 2014
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 Anaplastic Large Cell Lymphoma
Recurrent Adult Hodgkin Lymphoma
Recurrent Mantle Cell Lymphoma
Intervention Drug: tanespimycin
Enrollment 22
Recruitment Details Recruitment Period: 02/08/2005 through 05/08/2009. All participant recruitment attempted at UT MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title 17-AAG
Hide Arm/Group Description 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
Period Title: Overall Study
Started 22
Completed 18
Not Completed 4
Reason Not Completed
Death             3
Adverse Event             1
Arm/Group Title 17-AAG
Hide Arm/Group Description 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
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants
49.5
(25 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
6
  27.3%
Male
16
  72.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
1.Primary Outcome
Title Number of Patients With Response
Hide Description Number of participants who experience complete response or partial response. Partial Response=>50% decrease in lympho node masses. Complete Response=>-75% decrease in lymph node masses.
Time Frame Baseline to time to best response; Every 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intention to treat (ITT). All participants with baseline and at least one post baseline target lesion measurement were included.
Arm/Group Title 17-AAG
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
Complete Response 0
Partial Response 2
Time Frame 4 years and 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 17-AAG
Hide Arm/Group Description 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
All-Cause Mortality
17-AAG
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
17-AAG
Affected / at Risk (%)
Total   3/22 (13.64%) 
General disorders   
Death  1  3/22 (13.64%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
17-AAG
Affected / at Risk (%)
Total   21/22 (95.45%) 
Cardiac disorders   
Hypertension  1  3/22 (13.64%) 
Hypotension  1  2/22 (9.09%) 
Eye disorders   
Blurred Vision  1  3/22 (13.64%) 
Gastrointestinal disorders   
Diarrhea  1  8/22 (36.36%) 
Nausea  1  6/22 (27.27%) 
Vomiting  1  5/22 (22.73%) 
General disorders   
Fatigue  1  7/22 (31.82%) 
Pain  1  5/22 (22.73%) 
Fever  1  6/22 (27.27%) 
Metabolism and nutrition disorders   
Hypomagnesemia  1  4/22 (18.18%) 
Hypokalemia  1  2/22 (9.09%) 
Nervous system disorders   
Neuropathy  1  5/22 (22.73%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  4/22 (18.18%) 
Cough  1  2/22 (9.09%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  2/22 (9.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Anas Younes, MD / Professor
Organization: UT MD Anderson Cancer Center
EMail: etubbs@mdanderson.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00117988     History of Changes
Other Study ID Numbers: NCI-2009-00101
NCI-2009-00101 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000433593
2004-0792 ( Other Identifier: M D Anderson Cancer Center )
6936 ( Other Identifier: CTEP )
P30CA016672 ( U.S. NIH Grant/Contract )
R21CA117070 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2005
First Posted: July 11, 2005
Results First Submitted: May 5, 2011
Results First Posted: May 30, 2011
Last Update Posted: May 30, 2014