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- 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.
- To evaluate the safety and effectiveness of IMC-A12 treatment in individuals with mesothelioma who have previously had chemotherapy.
- Individuals at least 18 years of age who have been diagnosed with mesothelioma that has not responded to chemotherapy.
- 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.
Platinum-based chemotherapy is the standard of care for advanced unresectable malignant mesothelioma. New options for treatment are necessary in patients with advanced disease that have progressed on platinum-based therapy. The insulin-like growth factor (IGF) pathway is being studies in various malignancies including mesothelioma. IMC-A12 is an anti-IGF-1R monoclonal antibody that has shown activity in patients with various malignancies.
- To determine the clinical response rate (PR+CR) to IMC-A12 monotherapy in patients with advanced mesothelioma.
- To determine response duration, progression free survival (PFS) and overall survival (OS).
- To assess safety of IMC-A12 in patients with mesothelioma
- To evaluate tumor IGF-1R expression and correlation with response
- To correlate response to therapy with changes in FDG-PET imaging.
- To monitor serum mesothelin and CA-125 levels prior to and during therapy.
- Patients with histologically confirmed malignant pleural or peritoneal mesothelioma who have previously been treated on at least one platinum-containing chemotherapy regimen with progressive disease documented prior to study entry, or have refused cytotoxic chemotherapy.
- Measurable disease by modified RECIST criteria for pleural mesothelioma or by RECIST criteria for peritoneal mesothelioma.
- Adequate renal, hepatic and hematopoietic function.
- No major surgery, radiotherapy, chemotherapy or biologic therapy within 28 days of IMC-A12 therapy
- Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks.
- Treatment with IMC-A12 alone will continue until disease progression.
- Toxicity will be assessed every cycle by the CTEP Version 4.0 of CTCAE.
- Tumor response assessments will be performed every 2 cycles.
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
National Institutes of Health Clinical Center, 9000 Rockville Pike
National Institutes of Health Clinical Center (CC)
Published on BioPortfolio: 2014-08-27T03:12:17-0400
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