Goshen News, Goshen, IN

Local News

July 17, 2013

Clinical cancer trial at Goshen center seeking patients and partners

GOSHEN — A clinical trial ongoing at Goshen Center for Cancer Care might be a ray of light for some who thought there was no hope.

Currently, researchers at Goshen Center for Cancer Care are working with a group of 11 patients to see if a combination of drugs will help fight hypoxic tumors.

Dr. Alex Starodub, director of clinical research at the center, explained this particular trial involves the drugs TH-302 and Sunitinib (Sutent).

The patients in the trial have been treated for advanced renal cell carcinoma, gastrointestinal stromal tumors and pancreatic neuroendocrine tumors with the drug Sunitinib and have had a recurrence of cancer. The cancer is more aggressive and hypoxic, meaning there is low oxygen at the tumor site.

What is known

Researchers have learned that the cancer basically hijacks the blood supply normally used in healing. That’s why, as Dr. Starodub explained, doctors compare cancer “to a wound that never heals.”

So the research community started working on how to disrupt that signal. Researcher found that some cancers are more vascular than others, including colon cancer and kidney cancer. Colon cancer was treated with Avastin. And kidney cancer has been such a problem that up until eight years ago, researchers were unable to find a treatment that would work.

“A lot of people were discouraged,” Starodub said.

Medications, including Sunitinib, appeared.

Unlike Avastin, Sunitinib works on a different side of the cell membrane.

“What we saw was there was a sudden improvement in how long people lived without the cancer getting worse,” Starodub said. “There were some concerns that cancers that become hypoxic (not enough oxygen) would become more excessive. Several world-class labs showed in animals that’s exactly what happened.”

Research also showed a way the tumor can escape the medications that have been useful, he said.

“Because of those two things, people started thinking what else we can do?” Starodub said. “Can we develop medications that can attack a hypoxic tumor?”

A company developed the medication TH-302, that is similar to old-fashioned chemotherapy, he said, except it was completely inert and would only self-activate in a low oxygen area.

“It changes itself and becomes really, really toxic,” he said. “Outside of that (hypoxic area) it’s not.”

Starodub said there are some tissues in the human body that are a little bit hypoxic, so researchers do see some of that outside the tumor, too, but the impact is much less.

Through company guidance, researchers tested TH-302 in animals.

What they found: With cancer that was treated with Suditinib and regrows, the TH-302 would kill the tumors in animals.

“Naturally we are very excited about this,” Starodub said.”

The drug affects the tumor’s self-defense mechanism.

What they’re learning

So what researchers need to learn in humans is when they combine the two medications: what are the dosage levels needed and what are the results of the combinations.

Goshen Center for Cancer Care started a clinical trial to find the answers to those questions about 16 months ago.

Researchers have found nothing unexpected in the dosage, but there are some increased side effects, which are mostly manageable, Starodub said.

Goshen researchers have seen some good results early on.

“Some people have had a response to the treatment” after becoming resistant to Sutent (also known as Sunitinib),” Starodub said.

In those patients who were treated with the combination of the two drugs, researchers saw that the tumor could still be affected.

“There is a certain promise there,” Starodub said.

But that’s just phase 1.

Moving forward

Now, Goshen Center for Cancer Care’s researchers are looking for more partners and patients.

So far, Indiana University Simon Cancer Center and the University of Iowa have joined in the trial. And there are talks of adding one more site in California.

Anyone who has had any of the three forms of cancer, has been treated with Sunitinib and has had a recurrence, is invited to participate.

“If the Sutent is not working anymore,” Starodub said, “the options are more limited. So it makes sense to try this approach.”

Researchers would like about 13 more patients. Of the current 11 patients, none of them have pancreatic neuroendocrine tumors. However, they would welcome that type of patient as well for this particular phase of research.

“Clinical models are very positive for these patients,” Starodub said.

For patients who are Indiana residents, state law requires that insurance companies pay for the cost of clinical trials and the center has advocates for its patients to help them deal with insurance companies.

“But for the most part we don’t have a problem,” Starodub said.

Center officials are very familiar with the situation. They are currently working on about 40 cancer studies. Starodub himself is involved in about 20 of those.

“We have studies that are quite exciting, like melanoma, pancreatic and colon cancer,” he said.

For people who fit into the profile of this TH-302/Sunitinib clinical trial and are interested in participating, contact Goshen Center for Cancer Care at 574-364-1000.

More information about the center can be found online at iuhealth.org/goshen/cancer-care/


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