Clinical trial NCT02266355: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colon Cancer
Keywords: Oxaliplatin
Omalizumab
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Incidence of Recurrent HSR
timeFrame: up to 12 months
Secondary outcomes:
measure: Safety of Omalizumab
timeFrame: up to 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Stacey Stein, MD
role: PRINCIPAL_INVESTIGATOR
References: