Kaposi´s Sarcoma
Conditions
Keywords
Kaposi sarcoma, HIV, Bevacizumab
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.
Interventions
DRUGBevacizumab
Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
Sponsors
Centro de Investigación en. Enfermedades Infecciosas, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complete Response | 12 months | Complete response will be assessed according to RECIST criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HAART Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents | 7 |
| HAART+ Bevacizumab Injection Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3 | 7 |
| Total | 14 |
Baseline characteristics
| Characteristic | HAART+ Bevacizumab Injection | HAART | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 14 Participants |
| Age, Continuous | 35 years | 27 years | 30.5 years |
| Region of Enrollment Mexico | 7 participants | 7 participants | 14 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 | 1 / 7 |
Outcome results
Primary
Number of Participants With Complete Response
Complete response will be assessed according to RECIST criteria
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HAART | Number of Participants With Complete Response | 1 participants |
| HAART+ Bevacizumab Injection | Number of Participants With Complete Response | 3 participants |
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.
Time frame: 12 months