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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03160183
Recruitment Status : Active, not recruiting
First Posted : May 19, 2017
Last Update Posted : October 31, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

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.

Condition or disease
Kaposi Sarcoma HIV

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.

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Study Type : Observational
Actual Enrollment : 157 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Chemotherapy Treatments, Response and Subsets of HIV-associated Kaposi Sarcoma in Malawi
Study Start Date : September 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : April 2021





Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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:
  1. 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

  2. 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)

  3. The kind of KSHV strains in tumor biopsies, PBMC and plasma [ Time Frame: 48 weeks ]
    Viral genome features of HIV-associated KS

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160183


Locations
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Malawi
UNC Project, Lighthouse Trust
Lilongwe, Malawi
UNC Project
Lilongwe, Malawi
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sam Phiri, PhD,MSc, DCM UNC-CH
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03160183    
Other Study ID Numbers: LCCC 1424
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
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:
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Sarcoma, Kaposi
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Vascular Tissue