Investigating Chemotherapy Treatments, Response and Subsets of HIV-associated Kaposi Sarcoma in Malawi

HIV Clinical Trial

Official title:

Investigating Chemotherapy Treatments, Response and Subsets of HIV-associated Kaposi Sarcoma in Malawi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160183
• Other study ID #: LCCC 1424
• Status: Completed
• Start date: September 2016
• Est. completion date: October 1, 2020

Study information

• Verified date: December 2020
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to identify important associations between complete and comprehensive clinical, laboratory, and genomic data derived from patients and tumor specimens, with prospectively recorded clinical outcomes. The investigators also hope to move beyond simple risk factor associations as previously described, to develop a composite score specifically for KS recurrence or progression, analogous to widely used risk scores that are used to direct up-front treatment of other cancers. In so doing, the investigators will draw on extremely granular data to prospectively identify patients who are most likely to benefit from new treatments.

Description:

This is a prospective, nonrandomized, open-label, single arm, cohort study of pathologically confirmed HIV-associated KS patients initiating chemotherapy in Malawi. The primary objective of this study is to estimate the complete response rate (CR by ACTG criteria) at 48 weeks. This will be done both overall and by chemotherapy (BV or not BV) treatment group. Secondary objectives are to estimate PFS and OS for both overall and by chemotherapy treatment group. Exploratory objectives include the investigation of: select clinical variables and laboratory biomarkers among HIV-associated KS patients and their possible association with response, PFS, and OS; the histopathology of KSHV-associated lymphoproliferative diseases among HIV-associated KS patients; KSHV strains in tumor biopsies, PBMC and plasma, and KSHV gene expression characteristics between KS that develops on and off ART. The investigators plan to accrue 200 HIV-associated KS patients at a rate of approximately 50 patients per year. Approximately half of the patients will receive BV chemotherapy treatment. An important factor for this study's size is that it will be comparable to or exceed the size of other important KS cohort studies, which have demonstrated significant differences in outcomes based on gender or baseline KSHV DNA levels. The investigators want to show that there are definable biologic and clinical subsets within the HIV-associated KS population, and that identifying these subsets will have direct relevance to more effective treatment strategies for these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed KS initiating chemotherapy at Lighthouse Trust or the Kamuzu Central Hospital (KCH) Cancer Clinic
• HIV positive (confirmed at any time point prior by local standard of care assay) on or off ART
• Age =18 years
• Residence <200 kilometers from KCH
• Able to understand and comply with study procedures for the entire length of the study
• Subject able to understand and provide written consent in English or Chichewa Informed consent reviewed and signed by patient

Exclusion Criteria:

• Failure to meet inclusion criteria listed above.
• Specifically, pregnancy and breastfeeding are not exclusion criteria given the observational nature of the study with diagnostic and treatment interventions administered according to local standards of care.
• KS relapse disease as defined by a prior KS diagnosis within 1 year prior to enrollment.

Related Conditions & MeSH terms

• HIV
• Kaposi Sarcoma
• Sarcoma
• Sarcoma, Kaposi

Locations

Country	Name	City	State
Malawi	UNC Project	Lilongwe
Malawi	UNC Project, Lighthouse Trust	Lilongwe

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The clinical variables and laboratory biomarkers among HIV-associated KS patients and their possible association with response, PFS, and OS	The prevalence and nature of lymphoproliferative diseases among HIV-associated KS patients	48 weeks
Other	The histopathology of KSHV-associated lymphoproliferative diseases among HIV-associated KS patients	KSHV gene expression characteristics for HIV-associated KS that develops on and off antiretroviral therapy (ART)	48 weeks
Other	The kind of KSHV strains in tumor biopsies, PBMC and plasma	Viral genome features of HIV-associated KS	48 weeks
Other	The KSHV gene expression characteristics between KS that develops on and off ART	To describe KSHV gene expression characteristics between KS that develops on and off ART	48 weeks
Primary	Estimate the complete response rate (CR) at 48 weeks of HIV-associated KS patients overall and by BV treatment group.	the assessment of a patient's response (CR) to chemotherapy at 48 weeks by ACTG criteria	48 weeks
Secondary	Estimate the Progression Free Survival (PFS) in HIV-associated KS patients overall and by bleomycin-vincristine (BV) treatment group	PFS which will be defined as the time from treatment initiation until disease progression or death	48 weeks
Secondary	Estimate OS in HIV-associated KS patients overall and by BV treatment group	To estimate OS in HIV-associated KS patients overall and by BV treatment group	48 weeks