Clinical trials tests new treatments

August 15, 2012

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ATLANTA - A Dunwoody grandmother facing a life-threatening cancer took a pretty remarkable leap of faith. Carolyn Higgins says her treatment couldn't stop her cancer, so she signed up for a treatment that had never been tested in humans.

Higgins says she knew what she was getting herself into when she joined a phase-one clinical trial at Emory's Winship Cancer Institute.

Every two weeks she'd have to come in for an infusion of a unproven drug combination no-one else had tried. That was three and half years ago. Higgins has never looked back

"I never once thought about being a guinea pig," said Higgins. "I've never once thought of me as being an experiment."

Higgins, whose myeloma cancer came back after standard treatment, volunteered to be one of the first patients in the country to try a study drug. A study drug means researchers believe it has promise, but they don't know if it works.

"I made a deal with my Lord in Heaven and Dr. Lonial that I wanted a cure," said Higgins. "That is my cure, I didn't think about it any other way."

If your treatment isn't working, joining a clinical trial could be an option.

But Winship cancer research ethicist Dr. Rebecca Pentz says first you have to find the right study and the right treatment center.

"Then you need to find out what the extra things are in this trial. Every research has things that are just for the research and not for the patient," said Pentz.

You may have extra blood draws, biopsies, or lab tests and Dr. Pentz says you need to ask what your alternatives are.

"I always tell patients there's three things, you need to know: the risks, the benefits and the alternatives. Don't get through your conversation without finding out what the other options are. You want clearly in your mind that this is the right choice, and you make that decision," said Pentz.

Carolyn read an informed consent agreement twice. The risks, the side effects, what to expect, were all there in black and white.

"Because the drug company is involved, the FDA is involved, everything is by the book," said Higgins.

Clinical trials are done in stages to answer certain questions:

Phase 1: Is it safe?

Phase 2: Is it effective?

Phase 3: How does it compare to the standard treatments?


Pentz says volunteers can quit at any time.

"And you should know that here in our phase 1 clinic, we watch our patients like a hawk. And if we're sure this trial is not working out well for them and that they have too many side effects and it's just not good for them, we will pull them out in a heartbeat," said Pentz.

She's five years out from her diagnosis and is now part of a phase 2 trial.

"If this trial someday stops working, I'm raising my hand and going for another one. Because in those years, I'm sure the drugs will have gotten better," said Higgins.

Until then, Carolyn considers every day with her seven grandchildren a gift.

"They are the light of my life. I've told my children numerous times, I love them more than I love you! Because, because they love you like puppies," said Higgins.

A few more questions to ask before you sign up: what the purpose of the study is, how much of a time commitment is involved, and how it could affect your daily life.

To find out more about clinical trials going on in your community, go to www.clinicaltrials.gov.