Clinical trial NCT01160458
Conditions: Pleural Mesothelioma Peritoneal Mesothelioma
Keywords: Monoclonal Antibody Pleural Mesothelioma Peritoneal Mesothelioma
Sponsor: National Cancer Institute (NCI)
Start date: 2010-06-02; Completion date: 2017-02-24
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Arms: arm 1: 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)
Interventions: intervention 1: IMC-A12
Intervention descriptions: intervention 1: 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)

Protocol documents:
Prot_ICF_000.pdf: 
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