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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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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.
After the screening procedures confirm that eligibility:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure percentage of patients able to undergo reaction-free desensitizations. | Measure percentage of patients able to undergo reaction-free desensitizations. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
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)
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Hong, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Dana Farber Cancer Institute |
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| ID | Term |
|---|---|
| D004342 | Drug Hypersensitivity |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| 2 Years |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |