Drug AllergyPhase 1NCT02118987
Study of Omalizumab as Adjuvant Therapy in Chemotherapy Desensitization
A Phase 1 study testing Omalizumab in people with Drug Allergy, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Allergy
- What is being tested?
- Omalizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 1) cutaneous toxicity of the drug precludes testing
- 2) limited sensitivity of skin testing depending on the drug being tested with
Show all 13Show fewer
- 3) 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
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.
Read the detailed description
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.
- Conditions
- Drug Allergy
- Being tested
- Omalizumab
- Keywords
- Drug Desensitization, Hypersensitivity reactions to chemotherapeutic agents
- Medical subject headings
- Drug Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmalizumabDrug
Also called Xolair
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure percentage of patients able to undergo reaction-free desensitizations.
Measure percentage of patients able to undergo reaction-free desensitizations.
Measured: 2 Years
Secondary outcomes (1)
Skin test reactivity
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).
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AllergyStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, David I Hong, MD, Dana-Farber Cancer Institute
- Investigators
- David Hong, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118987
- Sponsor's protocol ID
- 13-485
- Status last verified
- Feb 2018
- First submitted
- 17 Apr 2014
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Omalizumab as Adjuvant Therapy in Chemotherapy Desensitization
- ClinicalTrials.gov ID
- NCT02118987
- Acronym / sponsor ID
- 13-485
- Conditions
- Drug Allergy
- Keywords
- Drug Desensitization, Hypersensitivity reactions to chemotherapeutic agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Jul 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omalizumab | Experimental | Drug: Omalizumab300mg 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmalizumabAlso: Xolair | Drug | Omalizumab |
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.
1 secondary outcome
Skin test reactivity
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
Related trials for Drug Allergy
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
Active, not recruitingPhase 2/3
Efficacy and Safety of Obinutuzumab Versus Rituximab in Childhood Steroid Dependant and Frequent Relapsing Nephrotic Syndrome
Steroid-Dependent Nephrotic Syndrome, Steroid-Sensitive Nephrotic Syndrome
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
RecruitingPhase 3
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
Atopic Dermatitis
RecruitingPhase 2
A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema
Atopic Dermatitis, Eczema, Atopic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hong, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omalizumab in people with Drug Allergy, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure percentage of patients able to undergo reaction-free desensitizations. (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.