Study of Omalizumab as Adjuvant Therapy in Chemotherapy Desensitization

NCT02118987 | Completed Phase 1 DMC

• 1 other identifier: 13-485
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Drug Allergy

Keywords

Drug Desensitization; Hypersensitivity reactions to chemotherapeutic agents

Outcome Measures

Primary Outcomes (1)

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

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

  2 Years

Secondary Outcomes (1)

• Skin test reactivity

  2 Years

Study Arms (1)

Omalizumab

EXPERIMENTAL

300mg of omalizumab under the skin every four weeks at three separate visits representing a treatment period of 12 weeks. During this treatment period, patients will continue receiving their regularly scheduled chemotherapy desensitizations per the prescribed treatment schedule from the patient's oncologist.

Drug: Omalizumab

Interventions

Omalizumab DRUG

Also known as: Xolair

Omalizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria on screening examination to be eligible to participate in the study:
• Patients with type I hypersensitivity reactions to chemotherapy agents including, but not exclusive to, platins, taxanes, or monoclonal agents as evidenced by typical IgE-mediated symptoms (ie. flushing, hives, dyspnea, wheezing, nausea, itchy eyes, nasal congestion, hypotension, angioedema)
• For various reasons, some, but not all, patients enrolled in the desensitization program may have positive skin test data to confirm an IgE-mediated reaction.
• These reasons include
• \) cutaneous toxicity of the drug precludes testing
• \) limited sensitivity of skin testing depending on the drug being tested with
• \) lack of adequate testing reagent and controls.
• Patients with breakthrough reactions requiring multiple desensitization interventions including 16 step protocols and intervention with additional antihistamine (requiring \>50mg IV diphenhydramine or po hydroxyzine; OR \>10mg cetirizine or loratadine)
• All cancer patients receiving chemotherapy agents, ages 18 and over.
• A positive skin test to the allergy-inducing agent or elevated tryptase level in the setting of infusion reaction.
• Clinical indication for additional doses of the chemotherapy as determined by the patient's oncologist.
• Patients stable enough to undergo chemotherapy as determined by the patient's oncologist.
• Ability to understand and the willingness to sign a written informed consent document.- We expect the majority of study patients to be women with ovarian cancer as this patient population frequently receives platin therapy with paclitaxel as first line therapy. This patient population also is at highest risk of developing hypersensitivity reactions to platin-based agents since these patients often receive multiple rounds of chemotherapy.

You may not qualify if:

• Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
• Medically unable to undergo desensitization.
• Unable to provide informed consent.
• Known sensitivity to omalizumab.
• Participants may not be receiving any other study agents.
• Chemotherapy treatment schedule \<12 weeks
• Pregnant women. Women of child-bearing potential should be using two forms of birth control while on the study. Should a woman become pregnant or suspect she is pregnant while participating in the study, she should inform her treating physician immediately.
• Uncontrolled illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with underlying primary mast cell disease (ie. mastocytosis)
• Pregnant women are excluded from this study because carboplatin, cisplatin, and oxaliplatin are chemotherapeutic agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with platin-based agents, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Drug Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• David Hong, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 21, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

US (2)