NCT01296815

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 27, 2015

Completed
Last Updated

July 27, 2015

Status Verified

July 1, 2015

Enrollment Period

2.3 years

First QC Date

February 15, 2011

Results QC Date

October 30, 2014

Last Update Submit

July 22, 2015

Conditions

Kaposi´s Sarcoma

Keywords

Kaposi sarcomaHIVBevacizumab

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Complete Response

    Complete response will be assessed according to RECIST criteria

    12 months

Secondary Outcomes (1)

  • Safety

    12 months

Study Arms (2)

HAART

NO INTERVENTION

Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents

HAART+ Bevacizumab injection

EXPERIMENTAL

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

Interventions

BevacizumabDRUG

Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3

Also known as: Avastin
HAART+ Bevacizumab injection

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • HIV infected
  • KS of the oral cavity, pharynx and larynx, histopathologically confirmed
  • HIV treatment-naïve

You may not qualify if:

  • Airway obstructive lesions
  • Actively bleeding lesions
  • Tumor-associated oedema or ulceration
  • Gastrointestinal KS
  • KS in other nonnodal viscera

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Investigacion en Enfermedades Infecciosas

México, State of Mexico, 14080, Mexico

Location

Related Publications (1)

  • 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: 25345840DERIVED

MeSH Terms

Conditions

Sarcoma, Kaposi

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSarcomaNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Gustavo Reyes-Teran
Organization
Centro de Investigación en. Enfermedades Infecciosas
gustavo.reyesteran@gmail.com
52 55 56667985

Study Officials

  • Gustavo Reyes-Teran, M.D.

    Centro de Investigacion en Enfermedades Infecciosas

    STUDY DIRECTOR

  • Yuria Ablanedo-Terrazas, M.D.

    Centro de Investigacion en Enfermedades Infecciosas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gustavo Reyes-Teran

Study Record Dates

First Submitted

February 15, 2011

First Posted

February 16, 2011

Study Start

September 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

July 27, 2015

Results First Posted

July 27, 2015

Record last verified: 2015-07

Locations

ME(1)