Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis

Centro de Investigación en. Enfermedades Infecciosas, Mexico

Status and phase: Unknown; Phase 2

Conditions: Recurrent Respiratory Papillomatosis

Treatments: Drug: Bevacizumab; Other: Placebo; Drug: Cidofovir

Study type: Interventional

Funder types: Other

Identifiers

NCT02555800

INER

Details and patient eligibility

About

The aim of this study is to compare the efficacy of intralesional bevacizumab, a monoclonal antibody against vascular endothelial growth factor, versus the antiviral drug cidofovir in patients with recurrent respiratory papillomatosis.

Full description

The investigators designed a randomized, double-blind, placebo-controlled study. Children and adults will be randomized to receive either 3 dosis of intralesional bevacizumab, cidofovir or saline solution. Primary endpoints are the assessment of changes in the annual surgery rate and Derkay papilloma severity grading scale; secondary endpoints are changes in the Voice Handicap Index and safety.

Enrollment: 36 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with recurrent respiratory papillomatosis proven by biopsy.
• Patients with 2 or more previous surgeries for papillomatosis

Exclusion criteria

• Patients with heart or renal disease
• Patients who receive another adjuvant therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups, including a placebo group

Bevacizumab

Experimental group

Description:

Patients will receive 3 intralesional injections of bevacizumab (Avastin, Genentech, San Francisco, California) every 3 to 6 weeks in a submucosal plane after surgical debulking. 12.5 mg of bevacizumab diluted in 3mL of 9% isotonic sodium chloride solution will be injected intralesionally using a 25 gauge.

Treatment:

Drug: Bevacizumab

Cidofovir

Experimental group

Description:

Patients will receive 3 intralesional injections of cidofovir every 3 to 6 weeks a submucosal plane after surgical debulking. 3.5 mL of cidofovir diluted to a concentration of 5 mg/mL in a 9% isotonic sodium chloride solution will be injected intralesionally using a 25 gauge.

Treatment:

Drug: Cidofovir

Saline

Placebo Comparator group

Description:

Patients will receive 3 intralesional injections of 3.5 mL of saline solution every 3 to 6 weeks in a submucosal plane after surgical debulking.

Treatment:

Other: Placebo