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Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00096538
Recruitment Status : Completed
First Posted : November 10, 2004
Results First Posted : November 25, 2015
Last Update Posted : November 25, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
New York Presbyterian Hospital
Weill Medical College of Cornell University
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sarcoma
Intervention Drug: valganciclovir
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valganciclovir
Hide Arm/Group Description Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
Period Title: Overall Study
Started 6
Completed 5
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Valganciclovir
Hide Arm/Group Description Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  16.7%
>=65 years
5
  83.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
0
   0.0%
Male
6
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Tumor Response Rate Every 4 Weeks
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Valganciclovir
Hide Arm/Group Description:
Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Progression of Disease 4
Stable Disease 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valganciclovir
Hide Arm/Group Description Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
All-Cause Mortality
Valganciclovir
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Valganciclovir
Affected / at Risk (%) # Events
Total   1/6 (16.67%)    
Blood and lymphatic system disorders   
Anemia  1  1/6 (16.67%)  1
Infections and infestations   
Skin infection  1  1/6 (16.67%)  1
Investigations   
Lymphocyte count decreased  1  1/6 (16.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Valganciclovir
Affected / at Risk (%) # Events
Total   2/6 (33.33%)    
Metabolism and nutrition disorders   
Hyperglycemia  1  2/6 (33.33%)  6
Skin and subcutaneous tissue disorders   
Rash/desquamation  1  1/6 (16.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ariela Noy
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-7423
EMail: noya@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00096538    
Other Study ID Numbers: 04-055
MSKCC-04055
First Submitted: November 9, 2004
First Posted: November 10, 2004
Results First Submitted: October 21, 2015
Results First Posted: November 25, 2015
Last Update Posted: November 25, 2015