Phase II Trial for the Treatment of Advanced Classical Kaposi's Sarcoma With the HIV Protease Inhibitor Indinavir in Combination With Chemotherapy
It has been recently demonstrated that HIV protease inhibitors (HIV-PI) exert direct
anti-angiogenic and anti-tumor actions by blocking endothelial and tumor cell invasion and
matrix metalloprotease (MMP) activity. Based on this data, we have started a phase II trial
for the treatment of HIV-negative patients with CKS with the HIV-PI Indinavir. Indinavir was
well tolerated and induced KS regression/improvement in early-stage disease, and prolonged
stabilization in late-stage KS. Response required high plasma drug concentrations indicating
a "therapeutic" drug threshold, and was associated with a decrease of circulating
endothelial cells (CEC), basic fibroblast growth factor and MMP2 plasma levels. However,
large, confluent tumor masses were generally not responsive (Monini et al, AIDS 2009). Thus,
advanced KS may benefit at best by treatment with IND upon tumor debulking by conventional
chemotherapy.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
to determine the rate of complete responses at the end of treatment (including the maintenance phase) and of clinical responses after the maintenance phase, considering the residual debulked tumour (after the induction phase) as the reference point.
No
Lucia Brambilla, MD
Principal Investigator
Dermatologic Unit, Ospedale Maggiore Policlinico, Milan, Italy
Italy: The Italian Medicines Agency
CKS/IND-CX/05
NCT01067690
June 2008
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