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Trial record 34 of 101 for:    Valcyte

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 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   --/--    
Show Serious Adverse Events 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)
Show Other (Not Including Serious) Adverse Events 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
Name/Title: Dr. Ariela Noy
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-7423
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00096538     History of Changes
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