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

NCT03160183 | Completed

• 1 other identifier: LCCC 1424
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Kaposi Sarcoma; HIV

Keywords

initiating chemotherapy; prospective, open label, single arm, cohort; non randomized, non interventional

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Estimate the Progression Free Survival (PFS) in HIV-associated KS patients overall and by bleomycin-vincristine (BV) treatment group

  48 weeks

• Estimate OS in HIV-associated KS patients overall and by BV treatment group

  48 weeks

Other Outcomes (4)

• The clinical variables and laboratory biomarkers among HIV-associated KS patients and their possible association with response, PFS, and OS

  48 weeks

• The histopathology of KSHV-associated lymphoproliferative diseases among HIV-associated KS patients

  48 weeks

• The kind of KSHV strains in tumor biopsies, PBMC and plasma

  48 weeks

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HIV-infected adults ≥18 years of age with pathologically confirmed KS who are initiating chemotherapy at Lighthouse Trust or the KCH Cancer Clinic.

You may qualify if:

• 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

You may not qualify if:

• KS relapse disease as defined by a prior KS diagnosis within 1 year prior to enrollment.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

UNC Project, Lighthouse Trust

Lilongwe, Malawi

Location

UNC Project

Lilongwe, Malawi

Location

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

  UNC-CH

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 19, 2017
• Study Start: September 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Locations

MA (2)