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| ID | Type | Description | Link |
|---|---|---|---|
| U54CA254564 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV-associated Kaposi Sarcoma | Patients receive standard-of-care chemotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard of care chemotherapy | Drug | intravenous Paclitaxel or the combination of Bleomycin and Vincristine. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) - 96 weeks | PFS will be defined as the time from chemotherapy treatment initiation 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. |
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Inclusion Criteria:
Participants meeting all the inclusion criteria listed below will be eligible for screening.
Exclusion Criteria:
Failure to meet the inclusion criteria listed above.
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Subjects with human immunodeficiency virus (HIV)-associated Kaposi Sarcoma (HIV-KS) receiving treatment at Study Site
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| Name | Affiliation | Role |
|---|---|---|
| Dirk Dittmer, PhD | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Project, Kamuzu Central Hospital | Lilongwe | Malawi | ||||
| Stellenbosch University and Tygerberg Hospital |
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| Label | URL |
|---|---|
| University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials | View source |
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| ID | Term |
|---|---|
| D012514 | Sarcoma, Kaposi |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Up to 96 weeks |
| Response rates (ORR) | Response rate will be assessed by Mucocutaneous and visceral Human immunodeficiency virus (HIV)-associated Kaposi Sarcoma (HIV-KS) separately according to protocol-defined definitions. ORR = Partial response (PR) or complete response (CR). Muco-Cutaneous Complete response (mcCR) is defined as the regression of all skin and/or mucosal lesions to hyperpigmented patches or macules if present at baseline. Muco-Cutaneous Partial response (mcPR) is defined as any reduction in the size, type and/or number of skin and/or mucosal lesions if present at baseline and no new manifestation of skin and/or mucosal lesions, not present at baseline. Visceral Complete response (vCR) is defined as the absence of symptomatic visceral KS if present at baseline. Visceral Partial response (vPR) is defined as any reduction in symptoms related to visceral HIV-KS if present at baseline and no new manifestation of symptoms related to visceral HIV-KS, not present at baseline. | Up to 4 weeks |
| Overall Survival (OS) | OS will be defined as the time from chemotherapy treatment initiation until death. | Up to 96 weeks |
| Health-related Quality of Life (HR-QOL) | HR-QOL will be measured by validated Human immunodeficiency virus (HIV)-associated Kaposi Sarcoma (HIV-KS) Functional Assessment of HIV (FAHI) Quality of Life instrument with 3 supplemental questions addressing pain, swelling, and satisfaction with physical appearance (FAHI+KS) as developed by the National Institutes of Health, will be used to collect quality of life (QOL) data in 5 categories: physical well-being, emotional well-being, functional and global well-being, social well-being, and cognitive functioning. Items are rated by patients on a Likert scale from 0 to 4. Higher scores represent worse QOL. | Baseline, 4 weeks, 48 weeks, 76 weeks, 96 weeks |
| Cape Town |
| Stellenbosch |
| 8000 |
| South Africa |
| D012509 |
| Sarcoma |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |