Pelotonia 2014 New Hope Clinical Trials 


Pelotonia Funding for Clinical Trials

Clinical trials demonstrate the safety and effectiveness of new treatments. Here are two Pelotonia-supported trials at the OSUCCC – James. For more information about these or other trials at The James, call The James Line toll free at 1-800-293-5066.


Kami.jpgAdult and pediatric patients with acute myeloid leukemia (AML) have a poor prognosis overall. New treatments that target the causes of AML and have minimal toxicity are needed.

Alison Walker, MD, an assistant professor in the Division of Hematology at Ohio State and a member of the Translational Therapeutics Program at the OSUCCC – James, is leading a phase I (first-in-human) clinical trial for one such treatment: a two-drug combination that could significantly improve AML remission rates. The trial is supported by Pelotonia funds.

“We have previously reported on the use of a drug called decitabine in older patients with AML,” Walker says. That earlier study showed the drug was well tolerated and helped 47 percent of patients who received it achieve remission.

They also observed that patients with higher levels of a substance in their blood called miR-29b had a better response to decitabine than those with lower levels.

The researchers have also discovered that a drug called AR-42, which was designed by OSUCCC – James researchers led by Ching-Shih Chen, PhD, increases levels of miR-29b in leukemia cells.
In this new clinical trial, patients first receive AR-42 to raise their miR-29b levels, then they receive decitabine therapy. Walker and colleagues want to determine whether this combination will help more patients achieve complete remission.

The trial is open to adult and pediatric patients who meet the study’s eligibility criteria.


Ramaswamy.jpgTriple-negative breast cancer (TNBC) is an aggressive malignancy that carries a high risk of recurrence and death within five years of diagnosis. To meet the need for new treatments, OSUCCC – James researchers are investigating novel combinations of targeted agents.

“TNBC accounts for approximately 20-25 percent of all breast cancers and is characterized by a lack of estrogen receptors, progesterone receptors and HER-2 receptors,” says Erin Macrae, MD, assistant professor of Medical Oncology at Ohio State and a breast cancer specialist at the OSUCCC – James.

Oncologists use the three hormone receptors to help determine treatment for breast cancer. “In other forms of breast cancer, treatments can be directed against these targets, but that’s not possible with TNBC,” Macrae says.

Macrae is principal investigator for a new phase II clinical trial (OSU-13117) – supported by Pelotonia funds – in which patients with TNBC initially receive a drug called trametinib, followed by trametinib in combination with a drug called GSK2141795. The investigators hypothesize that these agents may stop the growth of tumor cells by blocking enzymes needed for the cells to grow.

“TNBC is an important challenge because these tumors fail to respond to the targeted regimens that are currently available,” Macrae says. “Our study is exploring a novel regimen that we hope will help these patients.”

“Pelotonia funding helped support many of our laboratory and preclinical studies,” Ramaswamy notes. “Now we are using Pelotonia funds to study this target in triple-negative breast cancer (TNBC).” TNBC typically strikes younger women and has few treatment options and poor outcomes.

“Pelotonia support has been crucial in helping us understand this potential therapy, first in estrogen-resistant patients, and now Pelotonia funds are helping us obtain the data and translate the findings for a clinical trial in triple-negative breast cancer.”


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