Evaluating Quality of Life in Patients With AIDS-Associated Kaposi Sarcoma Treated With Bleomycin and Vincristine
brief summary
This pilot phase I trial studies how well treatment with vincristine and bleomycin affect quality of life in patients with acquired immunodeficiency syndrome (AIDS)-associated Kaposi sarcoma.
detailed description
PRIMARY OBJECTIVES:
I. To evaluate the longitudinal quality of life of participants with human immunodeficiency virus (HIV)-associated Kaposi sarcoma (KS) during treatment with bleomycin sulfate (bleomycin) and vincristine sulfate (vincristine) at a single institution in East Africa.
SECONDARY OBJECTIVES:
II. To explore baseline and time-dependent correlates of improvements in quality of life (QOL).
TERTIARY OBJECTIVES:
III. To assess quality control (completeness and accuracy) in data capture of adverse events, clinical benefit, and objective response for site evaluation and training purposes.
OUTLINE:
Patients receive vincristine intravenously (IV) over 1-2 minutes and bleomycin IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 12 weeks.
official title
Longitudinal Quality of Life Study Among Participants With AIDS-Associated Kaposi Sarcoma at Bugando Medical Centre, in Mwanza, Tanzania