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

Kaposi´s Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296815
• Other study ID #: C41-10
• Status: Completed
• Phase: Phase 2
• First received: February 15, 2011
• Last updated: July 22, 2015
• Start date: September 2010
• Est. completion date: December 2013

Study information

• Verified date: July 2015
• Source: Centro de Investigación en. Enfermedades Infecciosas, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• HIV infected

• KS of the oral cavity, pharynx and larynx, histopathologically confirmed

• HIV treatment-naïve

Exclusion Criteria:

• Airway obstructive lesions

• Actively bleeding lesions

• Tumor-associated oedema or ulceration

• Gastrointestinal KS

• KS in other nonnodal viscera

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS-Related Opportunistic Infections
• Kaposi´s Sarcoma
• Sarcoma
• Sarcoma, Kaposi

Intervention

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

Locations

Country	Name	City	State
Mexico	Centro de Investigacion en Enfermedades Infecciosas	Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Centro de Investigación en. Enfermedades Infecciosas, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Complete Response	Complete response will be assessed according to RECIST criteria	12 months	Yes
Secondary	Safety	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.	12 months	Yes