NCT01160458

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Background: 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. Objectives: Primary Objective: \- To determine the clinical response rate (partial response (PR)+complete response (CR)) to IMC-A12 monotherapy in patients with advanced mesothelioma. Secondary Objectives: * To determine response duration, progression free survival (PFS) and overall survival (OS). * To assess safety of IMC-A12 in patients with mesothelioma Exploratory Objectives: * To evaluate tumor IGF-1R expression and correlation with response * To correlate response to therapy with changes in fludeoxyglucose 18F-positron emission tomography (FDG-PET) imaging. * To monitor serum mesothelin and cancer antigen 125 or carbohydrate antigen 125 (CA-125) levels prior to and during therapy. Eligibility: * 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 Response Evaluation Criteria in Solid Tumors (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 Design: * 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 Cancer Therapy Evaluation Program (CTEP) Version 4.0 of Common Terminology Criteria for Adverse Events (CTCAE). * Tumor response assessments will be performed every 2 cycles.

Conditions

• Pleural Mesothelioma
• Peritoneal Mesothelioma

Interventions

Type	Name	Description
DRUG	IMC-A12	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)

Timeline

• Start date: 2010-06-02
• Primary completion: 2016-08-13
• Completion: 2017-02-24
• First posted: 2010-07-12
• Last updated: 2018-04-10
• Results posted: 2013-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study