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

Primary Purpose

Colon Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Omalizumab

About this trial

This is an interventional supportive care trial for Colon Cancer focused on measuring Oxaliplatin, Omalizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yale University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OmalizumabTreatment Group

Arm Description

Omalizumab (Xolair) 300 mg SQ every 2 weeks

Outcomes

Primary Outcome Measures

Incidence of Recurrent HSR

Recurrent Oxaliplatin HSR in subjects treated with omalizumab

Secondary Outcome Measures

Safety of Omalizumab

Evaluate the safety of omalizumab by assessment of frequency of adverse events and serious adverse events as categorized by CTCAE version 4

Full Information

NCT ID

NCT02266355

First Posted

October 10, 2014

Last Updated

May 28, 2019

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT02266355

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

February 27, 2018 (Actual)

Study Completion Date

February 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer

Keywords

Oxaliplatin, Omalizumab

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OmalizumabTreatment Group

Arm Type

Experimental

Arm Description

Omalizumab (Xolair) 300 mg SQ every 2 weeks

Intervention Type

Drug

Intervention Name(s)

Omalizumab

Other Intervention Name(s)

Xolair

Intervention Description

Omalizumab 300 mg SQ every 2 weeks

Primary Outcome Measure Information:

Title

Incidence of Recurrent HSR

Description

Recurrent Oxaliplatin HSR in subjects treated with omalizumab

Time Frame

up to 12 months

Secondary Outcome Measure Information:

Title

Safety of Omalizumab

Description

Evaluate the safety of omalizumab by assessment of frequency of adverse events and serious adverse events as categorized by CTCAE version 4

Time Frame

up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stacey Stein, MD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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