Latest Clinical Trial for Pleural Mesothelioma Opens in Georgia

Dr. Nagla Abdel Karim of the Georgia Cancer Center has seen the effectiveness of cabozantinib with certain types of thyroid, kidney and liver cancers.

She believes it may also work with pleural mesothelioma, making this rare and tough-to-treat cancer more manageable than it ever has been.

Karim has begun recruiting patients for the first phase I clinical trial involving cabozantinib for mesothelioma, anticipating a much-needed and long-awaited treatment advance for the cancer.

“I think this could become an effective treatment for mesothelioma, but you don’t know yet for sure,” Karim told The Mesothelioma Center at Asbestos.com. “This is a start, a small study, but the outlook is promising.”

Georgia Clinical Trial Looks for Synergy with Alimta

The Georgia Cancer Center, which is part of Augusta University, is hosting the initial clinical trial. Karim is the principal investigator. This study is open also to patients with lung cancer or urothelial cancer.

In the trial, the use of cabozantinib will be combined with standard-of-care Alimta, the chemotherapy drug generically known as pemetrexed. The study is designed to establish a safe and effective dosage level for both agents when used together.

Cabozantinib is known as an inhibitor. It blocks signals that encourage the growth of new blood vessels needed for cancer cells to divide and grow.

Blocking those signals can shrink tumors or even cause tumor cell death, leading to significantly longer survival for patients.

Cabozantinib will be taken orally on a daily basis, with gradually increasing dosage levels. The intravenous chemotherapy will be given every 21 days, involving four cycles.

“Right now, there is very little out there, very few treatment options, for mesothelioma patients,” Karim said. “The scientific rational for this combination is a good one.”

Mesothelioma Also Included in Second Clinical Trial

The clinical trial with cabozantinib is one of two at the Georgia Cancer Center that may help patients with mesothelioma.

Karim also is the principal investigator of a phase I clinical trial studying the use of bosutinib in combination with Alimta for selected metastatic solid tumors, including mesothelioma.

Bosutinib, much like cabozantinib, is an inhibitor drug designed to block a specific protein that stimulates cancer cells to grow. The Food and Drug Administration has approved it for certain types of leukemia. It is taken orally.

New Drug Combinations Key to Advancing Mesothelioma Treatment

There is no cure for mesothelioma cancer, which is caused almost exclusively by exposure to asbestos. Fewer than half of patients diagnosed with pleural mesothelioma live more than a year.

The most effective treatment includes a combination of aggressive surgery, chemotherapy and radiation. One problem, however, is that less than a third of those diagnosed even qualify for surgery because the cancer already is too advanced. Early symptoms are difficult to identify.

A majority of patients diagnosed with mesothelioma receive only standard chemotherapy, which makes new drugs such as cabozantinib so important in advancing treatment.

Novel immunotherapy drugs — which use a patient’s own immune system to fight the cancer — have been effective, but only for a small percentage of those diagnosed. The effectiveness has been limited.

Cabozantinib Trial Could Expand

Cabozantinib use was approved by the U.S. Food and Drug Administration for certain types of thyroid cancers in 2012. Approval for kidney and liver cancers followed.

An approval process for the drugs in this study could take several years before they become part of standard of care for pleural mesothelioma. Access to the combination in the early stages will be limited to clinical trials.

The trial’s primary measurement will be establishing the maximum tolerated dose of cabozantinib. Secondary measurements will be the objective response rate, progression-free survival and overall survival.

Karim believes the trial, if it shows early promise, will open in multiple locations across the country.

“It’s a small trial at this point, but we are looking for a big benefit,” she said.

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