At a glance
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Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy
In Brief
A Phase 2 clinical trial evaluating IMC-A12 for Pleural Mesothelioma and Peritoneal Mesothelioma. Completed, enrolled 20 participants across 1 site.
Detailed Summary
Background: Background: \- IMC-A12, a new cancer treatment that has not yet been approved by the U.S. Food and Drug Administration, is an antibody that is designed to block the effects of a protein called Type I Insulin-Like Growth Factor (IGF-1R). IMC-A12 blocks the receptors in cells that respond to IGF-1R, which are thought to play an important role in helping cancer cells to grow and divide. Researchers are interested in determining whether IMC-A12 is an effective treatment for individuals who have mesothelioma that has not responded to standard chemotherapy. Objectives: \- To evaluate the safety and effectiveness of IMC-A12 treatment in individuals with mesothelioma who have previously had chemotherapy. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with mesothelioma that has not responded to chemotherapy. Design: * Eligible participants will be screened with a full physical examination and medical history, blood and urine samples, and imaging studies. * Participants will receive IMC-A12 once every 3 weeks (21-day cycle), and will be evaluated before the start of each new cycle with blood tests and imaging studies if needed. * Treatment cycles will continue for as long as needed, unless severe side effects develop or the disease progresses.
Study Details
Timeline
Interventions
20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)