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Phase II Trial for the Treatment of Advanced Classical Kaposi's Sarcoma With the HIV Protease Inhibitor Indinavir in Combination With Chemotherapy

Phase 2
18 Years
Open (Enrolling)
Kaposi's Sarcoma

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Trial Information

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

Inclusion Criteria:

- Documented diagnosis of KS

- Negative HIV ELISA test

- Being classified as stage III or IV

- Age ≥18 years

- Having interrupted any other anti-KS therapy since at least 2 weeks

- Being informed about the nature of the study and having signed the informed consent

Exclusion Criteria:

- Inability to give informed consent

- Presence of other concomitant diseases, neoplasia (excluding cutaneous tumors with
limited extension and without diagnosis of melanoma) or any other life-threatening
clinical condition that would compromise its compliance to the protocol

- Concomitant treatments (within 2 weeks prior to the study) with systemic
immunomodulatory agents (i.e. glucocorticoids used as immunosuppressive agents,
interferons) or chemotherapy

- Pregnancy

- Monolateral nephropathy or history of nephrolithiasis during the last 5 years

- Any clinically relevant and persistent alteration of laboratory values observed
during screening

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Safety Issue:


Principal Investigator

Lucia Brambilla, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dermatologic Unit, Ospedale Maggiore Policlinico, Milan, Italy


Italy: The Italian Medicines Agency

Study ID:




Start Date:

June 2008

Completion Date:

Related Keywords:

  • Kaposi's Sarcoma
  • classical Kaposi's sarcoma
  • chemotherapy
  • indinavir
  • HIV protease inhibitor
  • Advanced classical (non HIV-associated) Kaposi's sarcoma
  • Sarcoma, Kaposi
  • Sarcoma