NCT03596918

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

Longitudinal Quality of Life Study Among Participants With AIDS-Associated Kaposi Sarcoma at Bugando Medical Centre, in Mwanza, Tanzania

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: AIDS Malignancy Consortium · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• AIDS-Related Kaposi Sarcoma
• Human Immunodeficiency Virus 1 Positive

Interventions

Type	Name	Description
BIOLOGICAL	Bleomycin Sulfate	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Vincristine Sulfate	Given IV

Timeline

• Start date: 2018-10-10
• Primary completion: 2020-06-13
• Completion: 2020-06-13
• First posted: 2018-07-24
• Last updated: 2026-02-11
• Results posted: 2022-07-25

Locations

1 site across 1 country: Tanzania