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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Centro de Investigación en. Enfermedades Infecciosas, Mexico.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centro de Investigación en. Enfermedades Infecciosas, Mexico
ClinicalTrials.gov Identifier:
NCT01296815
First received: February 15, 2011
Last updated: NA
Last verified: August 2010
History: No changes posted
  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:

Drug Information available for: Bevacizumab
U.S. FDA Resources

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

Primary Outcome Measures:
  • Size of lesions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Size of lesions 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.


Estimated Enrollment: 48
Study Start Date: September 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HAART Drug: Bevacizumab
Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
Experimental: HAART+ Bevacizumab injection Drug: Bevacizumab
Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296815

Contacts
Contact: Gustavo Reyes-Teran, M.D. +52(55)56667985 gustavo.reyesteran@cieni.org.mx
Contact: Yuria Ablanedo-Terrazas, M.D. +52(55)56667985 yuria.ablanedo@cieni.org.mx

Locations
Mexico
Centro de Investigacion en Enfermedades Infecciosas Recruiting
Mexico, Mexico, 14080
Contact: Gustavo Reyes-Teran, M.D.     +52(55)56667985        
Contact: Yuria Ablanedo-Terrazas, M.D.     +52(55)56667985        
Principal Investigator: Gustavo Reyes-Teran, M.D.            
Sub-Investigator: Yuria Ablanedo-Terrazas, M.D.            
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

Responsible Party: Gustavo Reyes-Teran, Centro de Investigación en Enfermedades Infecciosas
ClinicalTrials.gov Identifier: NCT01296815     History of Changes
Other Study ID Numbers: C41-10
Study First Received: February 15, 2011
Last Updated: February 15, 2011
Health Authority: Mexico: Ethics Committee

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

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

ClinicalTrials.gov processed this record on February 21, 2013