Role of Omalizumab in Reducing the Incidence of Oxaliplatin-induced Hypersensitivity Reaction

May 28, 2019 updated by: Yale University

A Pilot Study of the Role of Omalizumab (Xolair) in Reducing the Incidence of Oxaliplatin-induced Hypersensitivity Reaction (HSR)

Pilot study to evaluate the activity of omalizumab in the prevention of recurrent oxaliplatin hypersensitivity reaction (HSR) in oxaliplatin-sensitive patients. The study will also evaluate the safety of omalizumab (Xolair) when administered in this setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open label single arm pilot study studying the effects of omalizumab in the treatment of oxaliplatin hypersensitivity reaction (HSR) for patients with stage IV GI cancer.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinically evident HSR to oxaliplatin, with symptoms of flushing, urticaria, pruritus, rash, and/or dyspnea without bronchospasm that emerge during or shortly after of oxaliplatin infusion
  • Responding (complete or partial) or stable disease according to RECIST criteria while undergoing treatment with oxaliplatin containing regimen or need to resume an oxaliplatin based regimen in the setting of well-documented recent oxaliplatin hypersensitivity reaction
  • Histologically confirmed stage IV GI cancer (AJCC 7th edition) currently sensitive to oxaliplatin containing chemotherapy regimen
  • Age 18 years or older
  • ECOG performance status 0-2
  • Adequate bone marrow, liver, and kidney function. (WBC > 1500 cells/uL, platelets > 50,000/uL, ALT/AST < 5xULN (unless due to liver metastasis), Creatinine < 2.0 mg/ld)
  • Willing to give written informed consent, adhere to the visit schedules and meet study requirements

Exclusion Criteria:

  • Prior history of severe reactions to oxaliplatin as characterized by the presence of hemodynamic instability, significant respiratory symptoms or potential airway compromise
  • History of hypersensitivity reaction to Xolair or any ingredient of Xolair
  • Concurrent therapy with investigational agents
  • Use of any other investigational agent in the last 15 days and all toxicity of prior therapy resolved
  • Psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule
  • Women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding
  • Patients with severe medical conditions that in the view of the investigator prohibits participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: OmalizumabTreatment Group
Omalizumab (Xolair) 300 mg SQ every 2 weeks
Drug: Omalizumab
Omalizumab 300 mg SQ every 2 weeks
Other Names:
  • Xolair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Recurrent HSR
Time Frame: up to 12 months
Recurrent Oxaliplatin HSR in subjects treated with omalizumab
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Omalizumab
Time Frame: up to 12 months
Evaluate the safety of omalizumab by assessment of frequency of adverse events and serious adverse events as categorized by CTCAE version 4
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Stacey Stein, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (ACTUAL)

February 27, 2018

Study Completion (ACTUAL)

February 27, 2018

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

October 16, 2014

First Posted (ESTIMATE)

October 17, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2019

Last Update Submitted That Met QC Criteria

May 28, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1408014510

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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