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Imatinib Mesylate in Treating Patients With HIV-Related Kaposi's Sarcoma

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Consortium
ClinicalTrials.gov Identifier:
NCT00090987
First received: September 7, 2004
Last updated: August 27, 2014
Last verified: August 2014
History of Changes
Results First Received: May 25, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Sarcoma
Intervention: Drug: imatinib mesylate

  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
Date of Recruitment: August 4, 2005 to August 29, 2007 at 12 AMC clinical centers

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three patients withdrew from the study before receiving treatment.

Reporting Groups
  Description
Imatinib Mesylate (Gleevec) Imatinib mesylate (Gleevec) is administered 400 mg orally once a day

Participant Flow:   Overall Study
    Imatinib Mesylate (Gleevec)
STARTED   30 
COMPLETED   9 
NOT COMPLETED   21 
Adverse Event                5 
Lack of Efficacy                7 
Withdrawal by Subject                3 
alternative therapy                1 
Non-compliance                4 
Incarcerated                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
Imatinib Mesylate (Gleevec) Imatinib mesylate (Gleevec) is administered 400 mg orally once a day

Baseline Measures
   Imatinib Mesylate (Gleevec) 
Overall Participants Analyzed 
[Units: Participants]
 		 30 
Age 
[Units: Participants]
 		 
<=18 years   0 
Between 18 and 65 years   29 
>=65 years   1 
Age 
[Units: Years]
Mean (Standard Deviation) 		 43.2  (9.5) 
Gender 
[Units: Participants]
 		 
Female   1 
Male   29 
Region of Enrollment 
[Units: Participants]
 		 
United States   30 


  Outcome Measures

1.  Primary:   Proportion of Patients Who Achieve a Clinical Response   [ Time Frame: 20-24 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Inhibition of Platelet-derived Growth Factor-receptor as Assessed by Immunohistochemistry   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Cytokine Profiles Before and After Imatinib Therapy   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Pharmacokinetic Profile of Imatinib and Antiretrovirals   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Mechanisms of Primary and Secondary Resistance to Imatinib Therapy   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Viral Transcription Profile of Kaposi's Sarcoma-associated Herpesvirus   [ Time Frame: 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events
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  Other Adverse Events
  Show 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
No text entered.


  More Information
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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: Jeannette Y. Lee, Director of Statistical Center
Organization: AMC
phone: (501) 526-6712
e-mail: jylee@uams.edu


Publications:

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


Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT00090987     History of Changes
Other Study ID Numbers: AMC-042
U01CA070019 ( U.S. NIH Grant/Contract )
CDR0000380955 ( Other Identifier: NCI )
Study First Received: September 7, 2004
Results First Received: May 25, 2011
Last Updated: August 27, 2014