Study of Omalizumab as Adjuvant Therapy in Chemotherapy Desensitization

Drug Allergy Clinical Trial

Official title: Study of Omalizumab as Adjuvant Therapy in Chemotherapy Desensitization

Status Completed

Clinical Trial Summary

This research study is evaluating a drug called omalizumab (brand name 'Xolair') as a potential treatment to be used in conjunction with drug desensitization to prevent reactions from recurring and allowing the participant to be treated with the chemotherapy the participant's oncologist prefers to give.

Clinical Trial Description

After the screening procedures confirm that eligibility:

• The participant will receive a dose of 300mg of omalizumab under the skin every four weeks at three separate visits representing a treatment period of 12 weeks.

• During the entire course of the study, the participant will continue receiving their chemotherapy per their oncologist's prescribed schedule via desensitization supervised by an Allergy specialist from the BWH/DFCI Desensitization Team. The participant cannot receive omalizumab on the same day as their desensitization however.

• A careful review of the participant's symptoms will be done with each desensitization while on the study by filling out a questionnaire detailing what reactions, if any, the participant experienced with each desensitization during the study period. Additionally, the Allergy specialist will be documenting what complications, if any, were experienced in the participant's medical record, and this note will also be collected as part of their monitoring during the study period.

• The participant may have had skin testing to the agent they are being desensitized to in the course of the study. This would have been part of the initial allergy consultation prior to the participant's enrollment in the Desensitization Program. If the skin testing was positive, the participant will have to undergo repeat skin testing to that agent at the conclusion of the treatment period (week 12) to see if omalizumab is effective in changing skin test outcomes in participant's chemotherapy allergy. ;

Related Conditions & MeSH terms

• Drug Allergy
• Drug Hypersensitivity

• NCT number: NCT02118987
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Completed
• Phase: Phase 1
• Start date: July 2014
• Completion date: December 2017