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Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified May 2017 by UNC Lineberger Comprehensive Cancer Center

Sponsor
UNC Lineberger Comprehensive Cancer Center

Collaborator
National Cancer Institute (NCI)

Information provided by (Responsible Party)
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier
NCT03160183

First received: May 2, 2017
Last updated: May 17, 2017
Last Verified: May 2017
History of Changes
Purpose

Purpose

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.

Condition
Kaposi Sarcoma
HIV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Chemotherapy Treatments, Response and Subsets of HIV-associated Kaposi Sarcoma in Malawi

Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures

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

Estimated Enrollment: 200
Study Start Date: September 2016
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 99 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
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.

Criteria

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03160183

Contacts

Contact:   Agnes Moses, MBMS, MMed 265-1-755-056 amoses@unclilongwe.org

Locations

Malawi
UNC Project, Lighthouse Trust Recruiting
Lilongwe, Malawi
Contact: Sam Phiri, PhD    samphiri@lighthouse.org.mw
UNC Project Recruiting
Lilongwe, Malawi
Contact: Satish Gopal, MD    265-1-755-056    gopal@med.unc.edu

Sponsors and Collaborators

UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)

Investigators

Principal Investigator: Sam Phiri, PhD,MSc, DCM UNC-CH
More Information

More Information


Responsible Party: UNC Lineberger Comprehensive Cancer Center  
ClinicalTrials.gov Identifier: NCT03160183   History of Changes  
Other Study ID Numbers: LCCC 1424  
Study First Received: May 2, 2017  
Last Updated: May 17, 2017  
Individual Participant Data    
Plan to Share IPD: Undecided  

Keywords provided by UNC Lineberger Comprehensive Cancer Center:

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

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Kaposi

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.