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Clinical Trials for Leukemia
by Jill Spotz

Left to right: Daniel Medina, PhD, Dale Schaar, MD, PhD, and Roger Stair, MD, PhD.

One million hits is a major milestone — particularly for a new Web site. But New Jersey Cancer Trial Connect (NJCTC), a Web site listing all cancer clinical trials in New Jersey, can legitimately claim bragging rights to this staggering number. The site (www.njctc.org), launched in April 2003 by The Cancer Institute of New Jersey (CINJ), receives some 15,000 visits a day. It is taking much of the guesswork out of finding the best treatment options for cancer, the second leading cause of death in New Jersey.

NJCTC includes some 400 clinical trials across the state, many of them at CINJ and its partners and affiliates. Among the promising studies at CINJ are several for the treatment of myeloma, leukemia, Hodgkin’s lymphoma and other hematologic cancers. These disorders are characterized by uncontrolled growth of blood cells, which prevent the bone marrow from producing enough normal red and white blood cells and platelets.

In January, CINJ received a $740,000 grant from the Lymphoma Research Foundation for research into cures and treatments of mantle cell lymphoma. It is part of a larger overall grant of $12.8 million awarded to 18 institutions across the country. The project at CINJ will be directed by Roger Strair, MD, PhD, associate professor of medicine at UMDNJ-Robert Wood Johnson Medical School (RWJMS) and Daniel Medina, PhD, assistant professor of medicine at RWJMS, both members of the multidisciplinary Hematologic Malignancies Tumor Study Group at CINJ.

Mantle cell lymphoma, a relatively uncommon form of blood cancer primarily affecting older males, is characterized by a malignancy in the mantle zone of the lymph node, a thin area surrounding individual follicles. The investigators will be developing new therapies for testing in clinical trials. One of these therapies uses a virus that has been modified to kill the cancerous cells, but not the healthy ones. Another involves modifying the patient’s mantle cell lymphoma cells in a way that “tricks” the immune system into rejecting them.
Other trials at CINJ are investigating treatments for acute myelogenous leukemia (AML), a cancer of the white blood cells that originates in bone marrow, but can spread to the blood, lymph nodes, liver and other organs. It is one of the many subtypes of leukemia most commonly diagnosed in adults, with 10,000 new cases diagnosed each year.

Dale Schaar, MD, PhD, assistant professor of medicine at RWJMS, is studying the effects of 12-O-tetradecanoyl-phorbol-13-acetate (TPA), an ester extracted from a plant in China, on relapsed or refractory blood malignancies or bone disorders. In initial studies in China, treatment with TPA in conjunction with other agents resulted in some complete remissions, improved quality of life, and less need for transfusions. These findings prompted CINJ to launch the only Phase I clinical trial in the U.S. involving TPA. To date, 32 patients have been enrolled with some encouraging results. “In one patient, a tumor markedly regressed following TPA treatment,” says Schaar. “The future effects of TPA are promising, particularly since the dose we are currently testing in this dose escalation study is six times lower than what was originally used in China.”

Another trial directed by Strair focuses on an abnormality of leukemic stem cells: a family of transcription factors, called NFkappaB (NFKB), which is linked to chemoresistance, and ultimately, cancer relapse. The innovative therapy in this trial utilizes steroids and salicylates, along with standard chemotherapy, to inhibit NFKB function in leukemic stem cells.

“Our goal is to offer some form of treatment to every leukemia patient who enters CINJ’s doors — from high-risk patients to those with secondary leukemia or refractory relapse,” says Schaar.