Kaposi´s Sarcoma Clinical Trial
Official title:
Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity
Kaposi sarcoma remains the most common malignancy among persons with HIV.
Lesions localized to the airway may cause bleeding, pain and dyspnea.
New therapeutic approaches for local disease are needed.
The purpose of this study is to compare the effectiveness of intralesional bevacizumab +
HAART vs HAART alone in treating localized Kaposi´s sarcoma of the airway in patients with
AIDS.
Once disseminated disease is excluded, histologically confirmed HIV-positive patients with
localized Kaposi's sarcoma of the airway will be randomized to receive HAART only or HAART +
intralesional bevacizumab.
The primary outcome will be the size of lesions according to RECIST criteria. Patients in
the HAART + bevacizumab arm will undergo series of 3 bevacizumab injections of 5 mg/cm3.
Follow-up will be carried out through scheduled meetings for office setting examination
every week for the first 8 weeks, then every 15 days for two months and finally every month
for eight months.
Size of the lesions will be assessed by an independent observer and adverse events will be
recorded.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment