VOL. 125 | NO. 227 | Monday, November 22, 2010
SPECIAL COVERAGE on Health Care
The West Clinic Ramps Up Clinical Trials
By Tom Wilemon
The West Clinic will be doing more early-stage clinical trials so its doctors can prescribe and test cancer drugs straight from the discovery lab.
The West Clinic, 100 North Humphreys Boulevard, is performing more early-stageclinical trials to enhance its cancer treatments. (Photo: Lance Murphey)
The Memphis oncology practice is expanding its capabilities for Phase I trials, which will make potential new treatments available years before they come on the market.
“We have access to the same drugs that in the past only the major cancer centers in the country have had access to,” said Dr. Lee Schwartzberg, director of research at The West Clinic.
The West Clinic already participates in about 30 clinical trials annually, but those are primarily later stage Phase II and Phase III studies. Phase I trials typically test new treatments in small groups at select institutions before the studies are expanded. These studies are done according to the guidance of the U.S. Food and Drug Administration, the federal body that reviews the drugs for safety and efficacy.
New innovations with biopharmaceuticals, which are replacing chemical-based treatments, have somewhat blurred the traditional parameters for clinical trials.
“In the old days, Phase I trials were mainly about finding the safe dosage then taking it on to the Phase II testing, which is finding out how well they work,” Schwartzberg said. “But now that we understand the cancer biology better Phase I is also about finding signals of where drugs work.”
The West Clinic this year was one of 10 community-based oncology practices in the country to receive an award from the American Society of Clinical Oncology for efforts to improve cancer care through clinical trials. The practice works closely with ACORN Research LLC, also in Memphis. ACORN provides scientific expertise and administrative support for oncology practices to participate in clinical trials.
The freestanding company was spun off from The West Clinic. Schwartzberg serves as its lead founder, president and chief medical officer.
“It is through the relationship with ACORN that does the trial management for us that we are able to compete against the academic sites because we have good quality across all phases of the clinical research program,” he said.
Current or scheduled clinical trials at The West Clinic include treatments for breast cancer, prostate cancer, lung cancer and chronic lymphocytic leukemia.
Some of the new treatments are showing promise. One is a drug for breast cancer called a parp inhibitor. The West Clinic participated in a Phase III clinical trial for the drug, which disrupts chemotherapy resistance in cancer cells.
But with clinical studies, not every patient gets the new treatment. Patients are typically divided into a test group and a control group. The control group receives traditional therapies without the experimental drug. If the drug shows promise, The West Clinic can possibly make it available to more patients before market approval. The FDA could begin final review of the drug as early as next year.
“We now have expanded access protocol for that drug,” Schwartzberg said. “For patients who have a type of breast cancer called triple negative breast cancer, we can offer them the drug in expanded access until the drug is approved.”
With prostate cancer, The West Clinic will be offering vaccine therapy. The practice is also preparing for a trial involving b-raf inhibitors for treating melanoma. Other new trials are for lung cancer and other diseases.
“We are working on a very exciting protocol that we just opened with a gene therapy for chronic lymphocytic leukemia, where we harvest the blood cells and send them to make vaccine to basically stimulate the immune system,” Schwartzberg said. “We’re the second site in the country after the University of California in San Diego to participate in that.”