Phase 2
N=14
Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity
Kaposi´s Sarcoma
Bottom Line
View on ClinicalTrials.gov: NCT01296815 ↗Enrolled (actual)
14
Serious AEs
7.1%
Results posted
Jul 2015
Primary outcome: Primary: Number of Participants With Complete Response — 1; 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centro de Investigación en. Enfermedades Infecciosas, Mexico
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Response |
1; 3 | — |
| SECONDARY Safety |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01296815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.