Trial Outcomes & Findings for Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma (NCT NCT00096538)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

2 years

Results posted on

2015-11-25

Participant milestones
Measure	Valganciclovir 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 Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Valganciclovir 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 Study Withdrawal by Subject	1

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

Baseline characteristics by cohort
Measure	Valganciclovir n=6 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

Timeframe: 2 years

Outcome measures
Measure	Valganciclovir n=5 Participants 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.
Tumor Response Rate Every 4 Weeks Progression of Disease	4 participants
Tumor Response Rate Every 4 Weeks Stable Disease	1 participants

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events
Measure	Valganciclovir n=6 participants at risk 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.
Blood and lymphatic system disorders Anemia	16.7% 1/6 • Number of events 1
Infections and infestations Skin infection	16.7% 1/6 • Number of events 1
Investigations Lymphocyte count decreased	16.7% 1/6 • Number of events 1

Other adverse events
Measure	Valganciclovir n=6 participants at risk 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.
Metabolism and nutrition disorders Hyperglycemia	33.3% 2/6 • Number of events 6
Skin and subcutaneous tissue disorders Rash/desquamation	16.7% 1/6 • Number of events 1

Memorial Sloan Kettering Cancer Center

Phone: 212-639-7423