Stanford University begins clinical trial of old antidepressant that may b...

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Print (http://blog.cleveland.com/health_impact/print.html?entry=/2013/09 /stanford_university_begins_cli.html) (http://connect.cleveland.com/staff/atownsen/index.html) By Angela Townsend, The Plain Dealer (http://connect.cleveland.com/staff/atownsen/posts.html) Email the author | Follow on Twitter (https://twitter.com/atownzz) on September 27, 2013 at 6:00 AM, updated September 27, 2013 at 9:35 AM

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CLEVELAND, Ohio -Researchers at the Stanford University School of Medicine (http://med.stanford.edu/) in California have launched a Phase 2a clinical trial to test whether an antidepressant approved by the Food and Drug Administration more than 20 years ago has any effect in treating a deadly form of lung cancer.

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The trial, designed for patients with small-cell lung cancer (http://www.cancer.org/cancer/lungcancersmallcell/) and other, similar conditions like aggressive gastrointestinal neuroendocrine cancers, has already enrolled three people. Up to 15 people with no other treatment alternatives will be placed on the trial, in which they will take the drug imipramine (http://www.nlm.nih.gov/medlineplus/druginfo /meds/a682389.html) (brand name Tofranil) once a day by mouth.

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Imipramine is rarely prescribed for depression today; selective serotonin re-uptake inhibitors, or SSRIs, have fewer side effects and are now the preferred class of drugs for treating depression. Imipramine is also approved, however, to treat urinary frequency and incontinence, and to manage neurologic pain in patients with multiple sclerosis. The clinical trial is dose-escalating, which means patients get a higher dose gradually over time for as long as they are not bothered by side effects. Determining the highest possible dose is needed before expanding the study to include more patients. The trial evolved out a laboratory study, the results of which have been published online today in the journal Cancer Discovery (http://cancerdiscovery.aacrjournals.org/). The ability to move right into a Phase 2 trial is a "big financial deal and it's a time saver," said Julien Sage (http://med.stanford.edu/profiles/Julien_Sage/), associate professor of pediatrics and a co-senior author of the study. Sage said he estimates that hundreds of millions of dollars -- and years -- have been saved because of the laboratory research, initially a side project for postdoctoral scholar Nadine Jahchan, who was interested in looking at small-cell lung cancers. Within about six months of Jahchan's work, Sage said, it became clear that imipramine, a type of tricyclic antidepressant, was having positive effects on killing cancer cells grown in the lab and in mice. Small-cell lung cancers, which get their name from the size of the cancer cells when seen under a microscope, account for 10 to 15 percent of all lung cancers. It tends to spread quickly, and is often not detected in its early stage. About 31 percent of people diagnosed with Stage 1 small-cell lung cancer live at least five years after being diagnosed, according to the American Cancer Society. For those diagnosed with Stage 4 disease, the five-year survival drops to 2 percent. Jahchan and other researchers used a computerized discovery pipeline developed by NuMedii (http://numedii.com/), a start-up company that emerged from the Stanford lab of Dr. Atul Butte (http://med.stanford.edu/profiles /Atul_Butte). The technology -- involving scanning hundreds of thousands of gene-expression profiles (gathered by multiple researchers and stored in large databases) across many different cell types and tissues -- was designed to discover new uses for existing drugs that have already been FDA approved for something else. Once the computer program identified imipramine, Jahchan tested its effect on human small-cell lung cancer cells grown in the lab and growing as tumors in lab mice. It killed or slowed down the cells, even those that had become resistant to chemotherapy. The drug also slowed the growth of cells from pancreatic neuroendocrine cancers; a rare, aggressive skin cancer called Merkel cell carcinoma (http://www.skincancer.org/skin-cancer-information/merkelcell-carcinoma); and neuroblastoma (http://www.cancer.org/cancer

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/neuroblastoma/detailedguide/neuroblastoma-what-is-neuroblastoma), a pediatric cancer. Less than 20 months elapsed between the first discussion about the drug and the opening of the clinical trial. Although the technology has saved lots of time and money, the drug still needs to be tested to see if it actually works in humans, Sage said. "The message is that there is hope," he said. "Cancer is being attacked from many angles. This one may or may not work. But the more [drugs] we have, the faster we can test them and the more likely we are to find something that works."

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