Clinical trial NCT06480773: Kaposi Sarcoma Chemotherapy and Research (KS-CARE)
Official title: Kaposi Sarcoma Chemotherapy and Research (KS-CARE): Clinical and Molecular Determinants of HIV-associated Kaposi Sarcoma Progression Under Local Standard-of-care Therapy in Malawi and South Africa
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Kaposi Sarcoma
HIV
Keywords: Paclitaxel
Bleomycin
Vincristine
anti- retroviral
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
name: National Cancer Institute (NCI)
First posted: 2024-06-28
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with human immunodeficiency virus (HIV)-associated Kaposi Sarcoma (HIV-KS) receiving treatment at Study Site

Brief summary: This prospective, nonrandomized, open-label, single-arm, cohort study examines the effects of chemotherapy provided under local standard of care in patients with pathologically confirmed HIV-associated Kaposi Sarcoma (HIV-KS). Previous HIV-KS studies demonstrated significant variability in clinical outcomes based on differences in gender or baseline KSHV DNA levels in patients with HIV-KS.

Patients will receive chemotherapy according to local site treatment guidelines and standard of care. Chemotherapy regimen for two treatments that are used locally based on physician's choice namely intravenous (IV) Paclitaxel (PTX) or the combination of Bleomycin and Vincristine (BV). In addition, all histologically proven HIV-KS could be enrolled, irrespective of their prior length of combination anti-retroviral treatment (cART). This enrolment strategy will reflect a more realistic picture of HIV-KS management.

This study result could trigger treatment alteration of HIV-KS. The treatment approaches to HIV-KS can be individualized if clinically relevant subsets and novel prognostic markers are defined. In that case, newer and potentially more expensive agents can be selectively applied to those patients most likely to benefit, especially if prolonged treatment is needed.


Eligibility criteria: Inclusion Criteria:

Participants meeting all the inclusion criteria listed below will be eligible for screening.

* Histologically confirmed T1 KS presenting to TBH combined Kaposi Sarcoma clinic with or without visceral disease. no evidence of improvement in human immunodeficiency virus (HIV)-associated Kaposi Sarcoma (HIV-KS) in the 4 weeks immediately prior; and a clinical indication for systemic chemotherapy treatment
* Known HIV-1 infection status, as documented by any nationally approved, licensed HIV rapid test and confirmed at any time point prior by the local standard of care assay.
* On ART or not on ART.
* Age ≥18 years.
* Participants able to understand and provide written informed consent in English, Afrikaans, or isiXhosa.

Exclusion Criteria:

Failure to meet the 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.
* Specifically, the absence of skin lesions is not an exclusion criterion if recorded evidence of
* visceral or nodal disease is present in the form of a radiology or endoscopy report.
* Participants who have had prior chemotherapy or radiotherapy for human immunodeficiency virus (HIV)-associated Kaposi Sarcoma.
* Specifically, patients who have had prior cART will not be excluded.
* Participants who are receiving any other investigational agents.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Up to 48 weeks
Secondary outcomes:
measure: Progression Free Survival (PFS) - 96 weeks
timeFrame: Up to 96 weeks
measure: Response rates (ORR)
timeFrame: Up to 4 weeks
measure: Overall Survival (OS)
timeFrame: Up to 96 weeks
measure: Health-related Quality of Life (HR-QOL)
timeFrame: Baseline, 4 weeks, 48 weeks, 76 weeks, 96 weeks
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: UNC Project, Kamuzu Central Hospital
city: Cape Town
country: South Africa
facility: Stellenbosch University and Tygerberg Hospital
state: Stellenbosch
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Dirk Dittmer, PhD
role: PRINCIPAL_INVESTIGATOR
References: