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

Pleural Mesothelioma Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Lung Neoplasms
• Mesothelioma
• Peritoneal Mesothelioma
• Pleural Mesothelioma

• NCT number: NCT01160458
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Phase: Phase 2
• Start date: June 2, 2010
• Completion date: February 24, 2017