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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gustavo Reyes-Teran, Centro de Investigación en. Enfermedades Infecciosas, Mexico
ClinicalTrials.gov Identifier:
NCT01296815
First received: February 15, 2011
Last updated: July 22, 2015
Last verified: July 2015

February 15, 2011
July 22, 2015
September 2010
December 2012   (final data collection date for primary outcome measure)
Number of Participants With Complete Response [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Complete response will be assessed according to RECIST criteria
Size of lesions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Size of lesions will be assessed according to RECIST criteria
Complete list of historical versions of study NCT01296815 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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.
Same as current
Not Provided
Not Provided
 
Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity
Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Kaposi´s Sarcoma
Drug: Bevacizumab
Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
Other Name: Avastin
  • No Intervention: HAART
    Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
  • Experimental: HAART+ Bevacizumab injection
    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: Drug: Bevacizumab
Ablanedo-Terrazas Y, Alvarado-de la Barrera C, Ormsby CE, Ruiz-Cruz M, Reyes-Terán 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
December 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01296815
C41-10
No
Gustavo Reyes-Teran, Centro de Investigación en. Enfermedades Infecciosas, Mexico
Centro de Investigación en. Enfermedades Infecciosas, Mexico
Not Provided
Study Director: Gustavo Reyes-Teran, M.D. Centro de Investigacion en Enfermedades Infecciosas
Principal Investigator: Yuria Ablanedo-Terrazas, M.D. Centro de Investigacion en Enfermedades Infecciosas
Centro de Investigación en. Enfermedades Infecciosas, Mexico
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP