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

Phase 2

Completed

• Conditions: Kaposi´s Sarcoma
• Interventions: Drug: Bevacizumab

• Registration Number: NCT01296815
• Lead Sponsor: Centro de Investigación en. Enfermedades Infecciosas, Mexico

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 Description

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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-02-15
• Study First Submitted QC: 2011-02-15
• Study First Posted: 2011-02-16
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Results First Submitted: 2014-10-30
• Status Verified: 2015-07
• Results First Submitted QC: 2015-07-22
• Last Update Submitted: 2015-07-22
• Results First Posted: 2015-07-27
• Last Update Posted: 2015-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• HIV infected
• KS of the oral cavity, pharynx and larynx, histopathologically confirmed
• HIV treatment-naïve

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Exclusion Criteria

• Airway obstructive lesions
• Actively bleeding lesions
• Tumor-associated oedema or ulceration
• Gastrointestinal KS
• KS in other nonnodal viscera

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HAART+ Bevacizumab injection	Bevacizumab	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 Measures

Name	Time	Method
Number of Participants With Complete Response	12 months	Complete response will be assessed according to RECIST criteria

Secondary Outcome Measures

Name	Time	Method
Safety	12 months	Adverse events will be assessed according to the Council for International Organizations of Medical Sciences (CIOMS) I Working Group the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.

Trial Locations

Locations (1)

Centro de Investigacion en Enfermedades Infecciosas; 🇲🇽 Mexico, Mexico