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

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 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:

MedlinePlus related topics: HIV/AIDS Kaposi's Sarcoma Soft Tissue Sarcoma

Drug Information available for: Bevacizumab

Genetic and Rare Diseases Information Center resources: Soft Tissue Sarcoma Kaposi Sarcoma

U.S. FDA Resources

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

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.


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

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 (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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


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

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


Kaposi sarcoma HIV Bevacizumab

Additional relevant MeSH terms:


Immunologic Deficiency Syndromes 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 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

ClinicalTrials.gov processed this record on July 21, 2017