Evaluating Quality of Life in Patients With AIDS-Associated Kaposi Sarcoma Treated With Bleomycin and Vincristine

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• AIDS-Related Kaposi Sarcoma
• HIV Infections
• Human Immunodeficiency Virus 1 Positive
• Sarcoma
• Sarcoma, Kaposi

• NCT number: NCT03596918
• Study type: Observational
• Source: AIDS Malignancy Consortium
• Status: Completed
• Start date: October 10, 2018
• Completion date: June 13, 2020