Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity
Recruitment status was Recruiting
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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 |
- Size of lesions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Size of lesions will be assessed according to RECIST criteria
- 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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
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 |
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. |
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 |
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