NCI Is Seeking Mesothelioma Patients for New Clinical Trial
July 2, 2015
Patients with malignant mesothelioma can participate in an unprecedented clinical trial sponsored by the National Cancer Institute (NCI) that involves matching tumor-related genetic mutations with specific drugs that target the corresponding abnormality.
The clinical trial has the potential to change cancer treatment in the future, allowing doctors to prescribe drugs based on the molecular cause of the cancer, not the origin or source of the cancer. It could enhance the potential for treatment
“It is a unique, groundbreaking trial,” said NCI Acting Director Dr. Doug Lowy, when he announced the trial. “It is the first study in oncology that incorporates all of the tenets of precision medicine. There are no other cancer clinical trials of this size and scope that truly bring the promise of targeted treatment to patients whose cancers have specific genetic abnormalities.”
The name of the trial is NCI-MATCH (Molecular Analysis for Therapy Choice) and open enrollment begins in July. The exact date has not been announced.
Treatment for each individual patient will be based on a genetic abnormality, regardless of the cancer type, which is not the way cancers traditionally are treated. More than 20 different drugs will be used in the trial. Some of these will be experimental, while others are already approved by the U.S. Food and Drug Administration.
Two Enrollment Steps
The MATCH trial will include two enrollment steps. Each potential patient will be screened with a biopsy sample that will detect the possible genetic abnormality through DNA sequencing. As many as 3,000 patients will be screened.
If a molecular abnormality that is targeted by one of the drugs is uncovered, the patient will continue to the next phase. The goal is to find an estimated 1,000 patients, including 25 percent with rare cancers such as mesothelioma.
If a patient also meets the eligibility requirements for that particular phase of the trial, they will be treated with the targeted drug for as long they respond, with tumor shrinkage or tumor stability.
The NCI is expecting an estimated 2,400 different sites within its National Clinical Trials Network to be involved in the initial phase of the trial, making it readily available for most cancer patients.
All biopsy specimens will be sent to one of four genetic testing laboratories, which will use more than 4,000 variants across 143 different genes to make a possible treatment determination, regardless of tumor origin.
“What we’re trying to do is sequence their tumor for various cancer drivers,” said Dr. Barbara Conley, associate director of the NCI Cancer Diagnosis Program. “If they have that driver, they will be able to get the drug that was chosen to attack that driver.”
Looking for Participants with Common or Rare Cancers
The NCI is looking for participants with common cancers like non-small cell lung, colorectal, prostate and breast. Rare cancers sought include pleural and peritoneal mesothelioma, and cancers of the pituitary gland, ureter and eyes.
Among the drug companies participating are:
- Boerhringer Ingelheim
- Bristol-Myers Squibb
The treatments in the MATCH trial will be considered promising and incorporated into future studies by the NCI if at least 16 percent of patients have a complete or partial response. A secondary endpoint for success in the trial would be a six-month progression-free survival.
What’s the Cost to Participants?
There would be little cost to participants in the trial, which is a benefit of the NCI’s involvement. The biopsy and molecular tests, along with the drugs administered, are paid for by the NCI. The cost of tests, procedures and medicines to manage any side effects would be the responsibility of the participants or their insurance companies.
Interested participants should speak with their health care provider or call the Patient Advocates at Asbestos.com for more information. They also could call the NCI’s Cancer Information Service at 1-800-4-CANCER.
“It holds the potential to transform cancer care,” Lowy said.