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

This study has been completed.
Sponsor:
Collaborators:
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00090987
First received: September 7, 2004
Last updated: August 27, 2014
Last verified: August 2014
Results First Received: May 25, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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)  
Number of Participants  
[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 ]

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    Imatinib Mesylate (Gleevec)  
Total, other (not including serious) adverse events    
# participants affected / at risk     20/30  
Blood and lymphatic system disorders    
Blood/Bone Marrow    
# participants affected / at risk     2/30 (6.67%)  
# events     3  
Edema, limb    
# participants affected / at risk     6/30 (20.00%)  
# events     8  
Hemoglobin    
# participants affected / at risk     6/30 (20.00%)  
# events     7  
Leukocytes (total WBC)    
# participants affected / at risk     4/30 (13.33%)  
# events     6  
Neutrophil Count    
# participants affected / at risk     4/30 (13.33%)  
# events     7  
Platelets    
# participants affected / at risk     2/30 (6.67%)  
# events     2  
Gastrointestinal disorders    
Anorexia    
# participants affected / at risk     3/30 (10.00%)  
# events     3  
Constipation    
# participants affected / at risk     2/30 (6.67%)  
# events     2  
Diarrhea    
# participants affected / at risk     6/30 (20.00%)  
# events     7  
Gastrointestinal, other    
# participants affected / at risk     2/30 (6.67%)  
# events     2  
Nausea    
# participants affected / at risk     10/30 (33.33%)  
# events     14  
Pain, abdominal    
# participants affected / at risk     2/30 (6.67%)  
# events     2  
Taste Alteration    
# participants affected / at risk     2/30 (6.67%)  
# events     2  
Vomiting    
# participants affected / at risk     6/30 (20.00%)  
# events     9  
Abdominal bloating 1  
# participants affected / at risk     2/30 (6.67%)  
# events     2  
General disorders    
Fatigue    
# participants affected / at risk     5/30 (16.67%)  
# events     8  
Insomnia    
# participants affected / at risk     2/30 (6.67%)  
# events     2  
Metabolism and nutrition disorders    
ALT, SGPT    
# participants affected / at risk     2/30 (6.67%)  
# events     2  
Alkaline Phosphatase    
# participants affected / at risk     3/30 (10.00%)  
# events     3  
Amylase    
# participants affected / at risk     3/30 (10.00%)  
# events     10  
CPK    
# participants affected / at risk     3/30 (10.00%)  
# events     4  
Hyperbilirubinemia    
# participants affected / at risk     5/30 (16.67%)  
# events     10  
Hyperglycemia    
# participants affected / at risk     4/30 (13.33%)  
# events     6  
Hypocalcemia    
# participants affected / at risk     2/30 (6.67%)  
# events     4  
Hypokalemia    
# participants affected / at risk     4/30 (13.33%)  
# events     5  
Hypophosphatemia    
# participants affected / at risk     4/30 (13.33%)  
# events     9  
Metabolic/laboratory other    
# participants affected / at risk     3/30 (10.00%)  
# events     4  
Musculoskeletal and connective tissue disorders    
Pain, back    
# participants affected / at risk     2/30 (6.67%)  
# events     2  
Pain, extremity    
# participants affected / at risk     6/30 (20.00%)  
# events     6  
Pain, muscle    
# participants affected / at risk     3/30 (10.00%)  
# events     4  
Nervous system disorders    
Dizziness    
# participants affected / at risk     2/30 (6.67%)  
# events     2  
Respiratory, thoracic and mediastinal disorders    
Cough    
# participants affected / at risk     3/30 (10.00%)  
# events     4  
Dyspnea    
# participants affected / at risk     2/30 (6.67%)  
# events     2  
Pain, chest    
# participants affected / at risk     3/30 (10.00%)  
# events     3  
Skin and subcutaneous tissue disorders    
Bruising    
# participants affected / at risk     2/30 (6.67%)  
# events     2  
Dermatology/skin, other    
# participants affected / at risk     2/30 (6.67%)  
# events     2  
1 Term from vocabulary, MedDRA (10.0)



  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 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:

Responsible Party: AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier: NCT00090987     History of Changes
Other Study ID Numbers: AMC-042, U01CA070019, CDR0000380955
Study First Received: September 7, 2004
Results First Received: May 25, 2011
Last Updated: August 27, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board