New Clinical Trial Announced by the National Cancer Institute

Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy This study is currently recruiting patients. Sponsored by: National Cancer Institute (NCI) Information provided: National Institutes of Health Clinical Center (CC) ClinicalTrials.gov Identifier: NCT01160458 Purpose: Background: Background: – IMC-A12, a new cancer treatment that has not yet been approved […]

Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy

This study is currently recruiting patients.

Sponsored by: National Cancer Institute (NCI)
Information provided: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01160458

Purpose:

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.

Condition Intervention Phase
Pleural Mesothelioma
Peritoneal Mesothelioma
Drug: IMC-A12 Phase 2

Eligibility

Study Design: Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Official Title: Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy

Enrollment Size: Both

Gender: 18 Years

Min. Age: N/A

Max. Age: No

Location and Contact Information

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States
Status: Recruiting

Last modified: December 09, 2010.

 

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