AIDS-Related Kaposi Sarcoma Clinical Trial
Official title:
Longitudinal Quality of Life Study Among Participants With AIDS-Associated Kaposi Sarcoma at Bugando Medical Centre, in Mwanza, Tanzania
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.
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. ;
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