New Hope

Pelotonia Dollars Support Innovative Clinical Trials

Clinical trials evaluate the safety and effectiveness of new treatments and study ways to improve them. In this manner, clinical trials improve cancer care and bring renewed hope to patients. Here’s an example of how Pelotonia funds are helping to solve important questions related to a trial at the OSUCCC – James. To learn more about these and other trials, call The James Line at 800-293-5066 or visit cancer.osu.edu.

Pelotonia Funding Helps Thyroid Cancer Trial Answer Additional Questions


Besides comparing new therapies with a current standard of treatment, most clinical trials also include studies designed to learn more about the drug or the treatment being evaluated by the trial.

Pelotonia funds can be used to support these additional studies, known as correlative studies. For example, Pelotonia money is supporting a correlative study that is part of a clinical trial for a form of thyroid cancer called papillary thyroid carcinoma (PTC). About 80 percent of the 57,000 thyroid cancer cases expected in the United States in 2017 will be PTC.

Moreover, some 44 percent of PTC patients have a mutation in a gene called BRAF. The mutated genes send signals that cause cells to become cancerous and play a role in the development of thyroid, lung, melanoma and other cancers. But two targeted drugs, dabrafenib and trametinib, that have been approved by the U.S. Food and Drug Administration (FDA) for treating melanoma also show promise for treating cases of PTC that have BRAF mutations.

Dabrafenib blocks signals sent out by mutated BRAF, and trametinib targets a different gene that scientists believe helps PTC cells develop resistance to dabrafenib.

At the OSUCCC – James, a multicenter clinical trial led by medical oncologist Manisha Shah, MD, is testing the effectiveness of the two drugs.

About half of the 53 trial participants were treated with dabrafenib alone; the other half received dabrafenib plus trametinib. (Patients who took dabrafenib alone and whose disease began progressing were able to cross over into the group taking both agents.)

The trial was designed to show if BRAF-targeted therapies (one or two drugs) are effective and whether receiving the two drugs together would improve outcomes in PTC patients compared with PTC patients treated with dabrafenib alone. Last June at the annual meeting of the American Society of Clinical Oncology (ASCO), the OSUCCC – James team presented its findings that both dabrafenib alone and dabrafenib plus trametinib were well-tolerated by patients, resulting in a 50- to 54-percent response rate.

“Both therapy approaches resulted in positive outcomes for patients, and that gives us more treatment options,” says Shah, a member of the Translational Therapeutics Program at the OSUCCC – James. “Targeted therapy has the potential to change the standard of care for patients with this aggressive form of thyroid cancer.”

A Kinder, Gentler Biopsy


Shah and collaborators continue to follow patients in this trial to determine whether dabrafenib alone or combined with trametinib is more effective in the long term.

In addition, OSUCCC – James researchers are exploring other questions through the Pelotonia-supported correlative studies associated with this trial.

One of those studies is evaluating a procedure called liquid biopsy. Typically, biopsies for solid tumors such as PTC require needles, sometimes guided by ultrasound, to obtain a small tumor sample. For certain cancers, a biopsy requires a surgical procedure. The tumor sample is then studied by a pathologist, whose findings help determine optimum treatment.

A liquid biopsy involves the use of blood, urine or saliva samples, all of which can contain cell-free DNA. In people with cancer, dying tumor cells shed DNA into their circulatory system. This Pelotonia-supported correlative study is evaluating whether circulating tumor DNA in trial participants can predict how well they are responding to therapy or whether their tumor is progressing.

This study is the first to use this assay prospectively to follow treatment response and early detection of resistance in PTC.

Furthermore, the researchers will sequence the circulating tumor DNA to learn whether resistance mutations are present. This would be the first study of its kind in solid tumors performed at Ohio State. The scientists believe it could open the door for the analysis of other tumor types in which invasive biopsies are unattainable.

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