Phase II of the IMC-A12
in Patients With Mesothelioma Who Have Been
Previously Treated With Chemotherapy study is testing a new cancer treatment
that has yet to be approved by the U.S. Food and Drug Administration. IMC-A12 is an antibody designed to block the
effects of the Type I Insulin-Like Growth Factor (IGF-1R) protein by blocking
receptors in cells that respond to IGF-1R, theoretically preventing cancer
cells from growing and dividing. The
study’s objective is to determine how effective of a treatment IMC-A12 is in
individuals with mesothelioma cancer who
have not responded to standard chemotherapy.
In order to determine the clinical response rate,
response duration, progression free survival (PFS) and overall survival (OS)
and the safety of IMC-A12 in patients with mesothelioma,
participants will be treated with IMC-A12 once every 3 weeks. Mesothelioma doctors
will evaluate patients before the start of each new cycle with blood tests and
imaging studies if necessary. Treatment
will continue as long as needed, unless severe side effects develop or the
disease progresses.
The trial’s exploratory objectives include
evaluation of tumor IGF-1R expression and correlation with response, correlation
of response to therapy with changes in FDG-PET imaging and serum mesothelin and
monitoring of CA-125 levels prior to and during therapy. Toxicity will be assessed every cycle, and
tumor response assessments will be performed every two cycles.
Mesothelioma
is a rare type of cancer that occurs in the lining of the chest or abdomen. It
is more likely to develop in individuals who have been exposed to airborne
asbestos particles, and mesothelioma treatment
can include radiation, surgery, chemotherapy or a combination of the
three.
This mesothelioma
study began in June 2010 and is scheduled to end in April 2012. There is an estimated enrollment of 55
patients. All participants are screened with a full physical examination and
medical history, blood and urine samples, and imaging studies, and recruits
must be men or women 18 or older who have undergone chemotherapy
unsuccessfully, as platinum-based chemotherapy is the standard of care for
advanced unresectable malignant mesothelioma.
Patients
will only be eligible to take part in the trial if they have histologically
confirmed pleural or peritoneal mesothelioma not amenable to potentially
curative surgical resection. Patients
must have measurable disease (at least one lesion accurately measured as >
20 mm with conventional techniques or as > 10 mm with spiral CT scan) treated
at least once with a platinum-containing chemotherapy regimen. They must have a life expectancy of longer
than three months and must not have had major surgery, radiation therapy,
chemotherapy, biologic therapy or hormonal therapy (other than replacement),
within 4 weeks prior to the study.
Patients must also have a performance status (ECOG) less than or equal
to 2, a fasting serum glucose of < 160 mg/dL and adequate organ and marrow
function. Additionally, all recruits
must comply with an intravenous administration schedule and provide informed
consent.
For more
information visit: http://clinicaltrials.gov/ct2/show/NCT01160458?term=mesothelioma&rank=1or
contact the NCI Referral Office at ncicssc@mail.nih.gov or 1-888-NCI-1937. Refer
to the study by its ClinicalTrials.gov identifier: NCT01160458.
The
Mesothelioma and Asbestos Awareness Center is committed to providing up-to-date
information about mesothelioma cancer treatment and features a list of current
clinical trials, a database of the best mesothelioma doctors, and a listing of
the top U.S. cancer centers where patients can receive treatment for this
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