Kaposi Sarcoma Clinical Trial
Official title:
A Phase II Study With Tumor Molecular Pharmacodynamic (MPD) Evaluation of Oral mTOR-inhibitor Everolimus (RAD001) 10 mg Daily in Patients Suffering From Classic or Endemic Kaposi's Sarcoma
Classic Kaposi's sarcoma (CKS) is an angioproliferation associated with human herpes virus 8 (HHV8), which sometimes requires systemic treatment. Rapamycin and everolimus are mTOR inhibitors. The PI3K-AKT-mTOR pathway is activated in CKS.The aim of this study is to evaluate the rate of clinical response and tolerance to everolimus 10mg/d in CKS. Patients suffering from CKS will be enrolled in a multicenter two-stage phase II trial. At inclusion, all patients will have at least 10 lesions or more than one limb or 3% of body surface affected, in the absence of symptomatic visceral CKS. The primary endpoint is objective response to everolimus after 6 months therapy (complete or partial response per ACTG criteria). The trial is planned using Simon's minimax two-stage design to demonstrate a response rate of 50% as compared to 20% with type I error rate 2.5% and power of 90%. Accordingly, 11 patients will to be enrolled in the first stage and provided at least 3 patients responded, 15 patients will be accrued in a second stage.
The primary endpoint is objective response to everolimus after 6 months therapy (complete or
partial response per ACTG criteria).
Secondary endpoints are response according to physician global assessment, lesions size ,
lesions infiltration, lymphedema, tolerance, pharmacodynamic (pathologic, angiogenic and
lymphangiogenic biomarkers, HHV8 viral load sequential evaluation in the lesions,
pharmacokinetic evaluation.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06445166 -
Propranolol for the Treatment of Kaposi Sarcoma in Adults
|
Phase 2 | |
Recruiting |
NCT04941274 -
Abemaciclib in Patients With HIV-associated and HIV-negative Kaposi Sarcoma
|
Phase 1/Phase 2 | |
Completed |
NCT03160183 -
Investigating Chemotherapy Treatments, Response and Subsets of HIV-associated Kaposi Sarcoma in Malawi
|
||
Recruiting |
NCT03993106 -
A Study of sEphB4-HSA in Kaposi Sarcoma
|
Phase 2 | |
Recruiting |
NCT05081141 -
HHV8 and Solid Organ Transplantation
|
||
Completed |
NCT00395278 -
Development of Serologic Assays for Human Herpes Virus-8
|
||
Recruiting |
NCT02408861 -
Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
|
Phase 1 | |
Completed |
NCT03296553 -
Impact of Valganciclovir on Severe IRIS-Kaposi Sarcoma Mortality: an Open-label, Parallel, Randomized Controlled-trial.
|
Phase 2 | |
Recruiting |
NCT04305691 -
Trial of Ixazomib for Kaposi Sarcoma
|
Phase 2 | |
Completed |
NCT03316274 -
Intra-lesional Nivolumab Therapy for Limited Cutaneous Kaposi Sarcoma
|
Early Phase 1 | |
Recruiting |
NCT05859074 -
A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer
|
Phase 1 | |
Terminated |
NCT04893018 -
NT-I7 for Kaposi Sarcoma in Patients With or Without HIV
|
Phase 1 | |
Recruiting |
NCT06375122 -
Natural History Study of Kaposi Sarcoma
|
||
Recruiting |
NCT05663502 -
Collecting Blood and Tissue Sample Donations for Research for HIV/AIDS-Related Cancers
|
||
Recruiting |
NCT05329792 -
L19IL2/L19TNF in Skin Cancer Patients
|
Phase 2 | |
Not yet recruiting |
NCT05411237 -
Paclitaxel and Pegylated Liposomal Doxorubicin for Treatment of HIV-related Kaposi Sarcoma
|
Phase 3 | |
Completed |
NCT03050788 -
Smartphone Confocal Microscopy for Diagnosing Kaposi's Sarcoma
|
N/A | |
Completed |
NCT03404297 -
Compression Therapy for Leg Ulcers and Kaposi Sarcoma in Western Kenya
|
N/A | |
Not yet recruiting |
NCT06004011 -
AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)
|
N/A | |
Terminated |
NCT02080416 -
Nelfinavir for the Treatment of Gammaherpesvirus-Related Tumors
|
Phase 0 |