Amatuximab for High Mesothelin Cancers
Stopped early · Early Phase 1
Conditions studied: Carcinoma, Pancreatic Ductal, Mesothelioma, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung
In brief
Background: \- Amatuximab is a cancer treatment drug that targets mesothelin. High levels of this substance are found on some kinds of tumor cells. Lab studies have shown that amatuximab helps the immune system to kill cells that have high levels of mesothelin. However, more research is needed to determine how safe and effective amatuximab is for treating tumors with high levels of mesothelin. Objectives: \- To assess the safety and effectiveness of amatuximab in treating tumors with high levels of mesothelin. Eligibility: \- Individuals at least 18 years of age who have a type of cancer that overexpresses mesothelin. Design: * Participants will be screened with a medical history and physical exam. They will also have blood tests and tumor assessment studies. * Participants will have two intravenous doses of amatuximab several hours apart. Researchers will monitor them closely and do frequent blood draws. On the same day and also within 48 hours of the second dose, participants will have imaging studies. These studies will measure how well the amatuximab is working against the cancer. * Participants will have a third imaging study of the cancer about 1 week after the infusions. * Participants will have a followup visit 2 weeks after receiving amatuximab. This visit will require blood samples. Four weeks after receiving the drug, researchers will review patients symptoms or side effects. This interview can be done in person or by phone.
Key facts
- Study ID
- NCT01413451
- Run by
- National Cancer Institute (NCI)
- People needed
- 7
- Starts
- 2011-07-12
- Expected to finish
- 2013-11-15
- Last updated by the study team
- 2019-12-17
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Subjects are ineligible to participate in this study if any of the following criteria are met:
- Known allergy or hypersensitivity to monoclonal antibodies;
- Prior treatment with amatuximab;
- Prior treatment with SS1(dsFv)PE38 (SS1P);
- Known brain metastases;
- Known prosthetic devices that would prohibit imaging of lesion of interest due to radiographic artifact;
- Evidence of other active malignancy requiring treatment;
- Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class III or IV, angina not well controlled by medication, or myocardial infarction within 6 months);
- ECG demonstrating clinically significant arrhythmias. Subjects with chronic atrial arrhythmia, (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia), are eligible;
- Active serious systemic disease, including active bacterial or fungal infection within 2 weeks before study entry;
- Active viral hepatitis or symptomatic human immunodeficiency virus (HIV) infection;
- Treatment within 3 months with immunomodulatory therapy (e.g., interferons, immunoglobulin therapy, Interleukin 1 receptor antagonist (IL-1RA) or systemic corticosteroids). Short-term systemic corticosteroids or topical or intra-articular steroids are acceptable, at the discretion of the Investigator;
- Chemotherapy, biologic therapy, radiation therapy or immunotherapy within 3 weeks prior to dosing with amatuximab;
- Breast-feeding, pregnant, or likely to become pregnant during the study.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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