Phase II Study of IMC-A12 in Patients With Mesothelioma Who Have Been Previously Treated With Chemotherapy
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical Response Rate (PR+CR)
Clinical response is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is complete disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
36 months
No
Raffit Hassan, M.D.
Principal Investigator
National Cancer Institute (NCI)
United States: Federal Government
100146
NCT01160458
June 2010
July 2013
Name | Location |
---|---|
National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |