Clinical Trial: Study of Omalizumab as Adjuvant Therapy in Chemotherapy Desensitization

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.

Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: Measure percentage of patients able to undergo reaction-free desensitizations. [ Time Frame: 2 Years ]

Measure percentage of patients able to undergo reaction-free desensitizations.


Original Primary Outcome: Same as current

Current Secondary Outcome: Skin test reactivity [ Time Frame: 2 Years ]

Skin test reactivity to the patient's chemotherapy agent after completing the treatment phase of the study (omalizumab 300mg SC every 4 weeks x 3 treatments). Skin testing will only be done to those patients who have previously had a positive skin test to their agent with earlier drug allergy workup pre-dating enrollment in the trial (all candidate patients have had previous allergy workup to enroll in the desensitization program to begin with). Previous skin test data may not be available because A) the drug being desensitized to causes direct skin irritation, B) skin testing to the drug being desensitized to has unreliable sensitivity and/or specificity, or C) the diagnosis of drug allergy was strongly compelling enough to warrant desensitization even with a negative skin test. workup to enroll in the desensitization program to begin with).


Original Secondary Outcome: Same as current

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: April 17, 2014
Date Started: July 2014
Date Completion: December 2019
Last Updated: February 6, 2017
Last Verified: February 2017