Treatment With Indinavir and Chemotherapy for Advanced Classical Kaposi's Sarcoma

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the clinical response to daily Indinavir oral administration in association with a conventional chemotherapy based on cycles of systemic Vinblastine +/- Bleomycin in patients affected by advanced classical (non HIV-associated) Kaposi's sarcoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ensoli, MD, PhD
• Treatments: Bleomycin; HIV Protease Inhibitors; Indinavir; Protease Inhibitors

Criteria

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