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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01296815
Recruitment Status : Completed
First Posted : February 16, 2011
Results First Posted : July 27, 2015
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):
Gustavo Reyes-Teran, Centro de Investigación en. Enfermedades Infecciosas, Mexico

Tracking Information
First Submitted Date  ICMJE February 15, 2011
First Posted Date  ICMJE February 16, 2011
Results First Submitted Date  ICMJE October 30, 2014
Results First Posted Date  ICMJE July 27, 2015
Last Update Posted Date July 27, 2015
Study Start Date  ICMJE September 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2015)
Number of Participants With Complete Response [ Time Frame: 12 months ]
Complete response will be assessed according to RECIST criteria
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2011)
Size of lesions [ Time Frame: 12 months ]
Size of lesions will be assessed according to RECIST criteria
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2011)
Safety [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity
Official Title  ICMJE Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kaposi´s Sarcoma
Intervention  ICMJE Drug: Bevacizumab
Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
Other Name: Avastin
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2015)
14
Original Estimated Enrollment  ICMJE
 (submitted: February 15, 2011)
48
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01296815
Other Study ID Numbers  ICMJE C41-10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gustavo Reyes-Teran, Centro de Investigación en. Enfermedades Infecciosas, Mexico
Study Sponsor  ICMJE Centro de Investigación en. Enfermedades Infecciosas, Mexico
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Centro de Investigación en. Enfermedades Infecciosas, Mexico
Verification Date July 2015

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