Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity

Conditions

• Kaposi´s Sarcoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — DRUG
  Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3

Study Details

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.

Key Dates

First listed

Feb 16, 2011

Start date

Sep 30, 2010

Status verified

Jul 2015

Primary completion

Dec 31, 2012

Completion

Dec 31, 2013

Study Design

Enrollment

14 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: HAART
  Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
• Experimental: HAART+ Bevacizumab injection
  Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Patients received 3 intralesional injections of bevacizumab (Avastin, Genentech, San Francisco, California) in the target lesion every 2 weeks. Bevacizumab was injected using an insulin syringe in a submucosal plane. The volume injected was based on the size of the target lesion; the dose was 0.2 mL (5 mg) per cm2.

Primary Outcome Measure

Number of Participants With Complete Response [ Time Frame: 12 months ]