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
  Purpose

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 Intervention Phase
Kaposi´s Sarcoma
Drug: Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity

Resource links provided by NLM:


Further study details as provided by Centro de Investigación en. Enfermedades Infecciosas, Mexico:

Primary Outcome Measures:
  • Number of Participants With Complete Response [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Complete response will be assessed according to RECIST criteria


Secondary Outcome Measures:
  • 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.


Enrollment: 14
Study Start Date: September 2010
Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Centro de Investigación en. Enfermedades Infecciosas, Mexico

Additional 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
Study First Received: February 15, 2011
Results First Received: October 30, 2014
Last Updated: July 22, 2015
Health Authority: Mexico: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 01, 2015