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

2014-08-27 03:12:17 | BioPortfolio

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.

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 (PR+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 FDG-PET imaging.

- To monitor serum mesothelin and 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 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 CTEP Version 4.0 of CTCAE.

- Tumor response assessments will be performed every 2 cycles.

Study Design

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

Conditions

Pleural Mesothelioma

Intervention

IMC-A12

Location

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

Status

Recruiting

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:17-0400

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