Kaposi Sarcoma Chemotherapy and Research (KS-CARE)

NCT06480773 | Active Not Recruiting DMC

• 2 other identifiers: KS-CAREU54CA254564
• Study Type: observational
• Target: 127
• Locations: 2 countries
• Sites: 2

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.

Conditions

Kaposi Sarcoma; HIV

Keywords

Paclitaxel; Bleomycin; Vincristine; anti- retroviral

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS will be defined as first chemotherapy day until disease progression. Mucocutaneous and visceral Human immunodeficiency virus (HIV)-associated Kaposi Sarcoma (HIV-KS) response will be assessed separately according to protocol-defined definitions. Mucocutaneous Progressive disease (mcPD) is defined as any increase or progression in the size, type and/or number of skin and/or mucosal lesions if present at baseline or new lesion. Visceral Progressive disease (vPD) is defined as any increase in symptoms related to visceral HIV-KS if present at baseline or a new manifestation of symptoms related to visceral HIV-KS, not present at baseline, or radiological or endoscopic evidence of visceral KS, not present at baseline. Notably, lymphoedema and nodal disease will not be part of the formal response assessment for CR, PR, and SD response criteria should have been maintained for at least 4 weeks. For PD response criteria can have been present for at least 1 week.

  Up to 48 weeks

Secondary Outcomes (4)

• Progression Free Survival (PFS) - 96 weeks

  Up to 96 weeks

• Response rates (ORR)

  Up to 4 weeks

• Overall Survival (OS)

  Up to 96 weeks

• Health-related Quality of Life (HR-QOL)

  Baseline, 4 weeks, 48 weeks, 76 weeks, 96 weeks

Study Arms (1)

HIV-associated Kaposi Sarcoma

Patients receive standard-of-care chemotherapy.

Drug: standard of care chemotherapy

Interventions

standard of care chemotherapy DRUG

intravenous Paclitaxel or the combination of Bleomycin and Vincristine.

HIV-associated Kaposi Sarcoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with human immunodeficiency virus (HIV)-associated Kaposi Sarcoma (HIV-KS) receiving treatment at Study Site

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

UNC Project, Kamuzu Central Hospital

Lilongwe, Malawi

Location

Stellenbosch University and Tygerberg Hospital

Cape Town, Stellenbosch, 8000, South Africa

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Sarcoma, Kaposi

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Study Officials

• Dirk Dittmer, PhD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: April 25, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1); MA (1)