Clinical Trial: Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity
Brief Summary:
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.
Detailed Summary:
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.
Sponsor: Centro de Investigación en. Enfermedades Infecciosas, Mexico
Current Primary Outcome: Number of Participants With Complete Response [ Time Frame: 12 months ]
Original Primary Outcome: Size of lesions [ Time Frame: 12 months ]
Current Secondary Outcome: Safety [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Centro de Investigación en. Enfermedades Infecciosas, Mexico
Dates:
Date Received: February 15, 2011
Date Started: September 2010
Date Completion:
Last Updated: July 22, 2015
Last Verified: July 2015
