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NCT01296815 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2015-07-27

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Complete Response

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outcome · NOT POSTED

Safety

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
maximum Age
60 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
    label
    HAART
    type
    NO_INTERVENTION
  2. description
    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.
    intervention Names
    1. Drug: Bevacizumab
    label
    HAART+ Bevacizumab injection
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. HAART+ Bevacizumab injection
    description
    Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
    name
    Bevacizumab
    other Names
    1. Avastin
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
14
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Complete response will be assessed according to RECIST criteria
    measure
    Number of Participants With Complete Response
    time Frame
    12 months
secondary Outcomes
  1. description
    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.
    measure
    Safety
    time Frame
    12 months
Full study description
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.
Source references
references
  1. citation
    Ablanedo-Terrazas Y, Alvarado-de la Barrera C, Ormsby CE, Ruiz-Cruz M, Reyes-Teran G. Intralesional bevacizumab in patients with human immunodeficiency virus-associated Kaposi's sarcoma in the upper airway. Laryngoscope. 2015 Apr;125(4):E132-7. doi: 10.1002/lary.24988. Epub 2014 Oct 27.
    pmid
    25345840
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        exact text
        NCT01296815
        start
        0
      offset unit
      unicode_code_points
      query cond
      Laryngeal Cancer
      query disease state id
      ds-laryngeal-cancer
      source file
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    Preserved source evidence · Not medical advice