Research & Clinical Trials

National Cancer Institute Opening Two New Trials for Mesothelioma Patients

Written By:
Dec 22, 2011
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Written By: Tim Povtak,
December 22, 2011

The steps often have been slow, but Dr. Raffit Hassan in Bethesda, Maryland, keeps plugging away in the search for better options to treat malignant mesothelioma.

He never has been more optimistic.

Hassan, a senior investigator at the National Cancer Institute, has opened two new clinical trials for patients who already have received standard care that has failed to be effective.

Both trials involve immunotoxins, a human-made protein that includes a targeted portion linked to a toxin designed to kill the cancer cells. Mesothelioma is the cancer caused by exposure to asbestos.

The first is a study of pentostatin plus cyclophosphamide immune depletion. It is for patients with tumors that are not eligible for curative surgical resection. To be eligible for the trial, a patient must have been previously treated with at least one platinum-containing chemotherapy round.

Each treatment cycle in the study — patients can receive up to three — will consist of pentostatin intravenously, cyclophosphamide pills and SS1P, also taken intravenously.

Increasing Dose of Antibody Drug

The second new trial is a dose escalation study of BAY94-9343, an antibody drug conjugate, to find the maximum tolerated dose. It is aimed at patients with an advanced solid tumor that has not responded to standard therapy.

Each treatment will consist of BAY94-9343 given intravenously every 21 days. Cycles will continue for as long as there is no progressive disease or unacceptable toxicity.

“There is a better understanding of this disease and the treatment options than there ever has been,” Hassan said in a recent interview with the Mesothelioma Center. “I’m confident in the recent advances, and we’ll continue to learn more with these trials.”

In addition to these latest phase I trials, Hassan also has been overseeing a phase II study of IMC-A12, or cixutumumab, an antibody that has shown considerable promise in treating mesothelioma patients.

The advantage of participating in a trial at the National Cancer Institute can be substantial. There is no charge for medical care. And the NCI trials are open to anyone, regardless of where they live in the United States.

Patients are responsible for travel costs for the initial screening, but if they are accepted into the trial, they will be reimbursed for all subsequent visits if they live outside the area.

“A rare disease [like mesothelioma] can make it difficult to conduct big trials, but there is no better place to do them,” Hassan said. “We’re moving in the right direction.”

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