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

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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):

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.


Condition or disease Intervention/treatment Phase
Kaposi´s Sarcoma Drug: Bevacizumab Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity
Study Start Date : September 2010
Primary Completion Date : December 2012
Study Completion Date : December 2013


Arms and Interventions

Arm Intervention/treatment
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.
Drug: Bevacizumab
Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
Other Name: Avastin


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Complete Response [ Time Frame: 12 months ]
    Complete response will be assessed according to RECIST criteria


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296815


Locations
Mexico
Centro de Investigacion en Enfermedades Infecciosas
Mexico, Mexico, 14080
Sponsors and Collaborators
Centro de Investigación en. Enfermedades Infecciosas, Mexico
Investigators
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gustavo Reyes-Teran, Centro de Investigación en. Enfermedades Infecciosas, Mexico
ClinicalTrials.gov Identifier: NCT01296815     History of Changes
Other Study ID Numbers: C41-10
First Posted: February 16, 2011    Key Record Dates
Results First Posted: July 27, 2015
Last Update Posted: July 27, 2015
Last Verified: July 2015

Keywords provided by Gustavo Reyes-Teran, Centro de Investigación en. Enfermedades Infecciosas, Mexico:
Kaposi sarcoma
HIV
Bevacizumab

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Kaposi
AIDS-Related Opportunistic Infections
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Vascular Tissue
Opportunistic Infections
Infection
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Parasitic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Bevacizumab
Anti-Retroviral Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents