Phase I NIH-Funded Study of Chemotherapy Drug Topotecan
Drug Delivered Directly to Brain Tumor, Bypassing Blood-Brain Barrier
Nov 23, 2004
As part of an ongoing Phase I NIH-funded study, brain tumor patients at NewYork-Presbyterian Hospital/Columbia University Medical Center are being treated with a novel chemotherapy treatment, in which the drug topotecan is administered directly into the brain tumor through catheters. Traditional intravenous chemotherapy cannot treat brain tumors due to limitations caused by the blood-brain barrier, which prevents drugs from entering the brain. NewYork-Presbyterian Hospital/Columbia University Medical Center is the only medical center worldwide where the treatment is available.
The study hopes to show that the treatment – called convection-enhanced delivery – is safe and effective, slows tumor growth, improves quality of life, and lengthens survival for patients with malignant and recurrent gliomas – a type of tumor that originates in the brain.
"Six patients so far have received topotecan and none have experienced any significant side effects," says Dr. Jeffrey Bruce, attending neurosurgeon at NewYork-Presbyterian/Columbia and professor of neurological surgery at Columbia University College of Physicians and Surgeons. The drug has previously been shown to reduce tumor size in animal and other laboratory studies.
With convection-enhanced delivery, developed in the mid-1990s by NIH researchers, a slow steady flow of chemotherapy builds up pressure in the brain, pushing the drug into the tumor and surrounding brain tissue. This allows for higher drug concentrations and better distribution of the drug into the brain.
Brain tumors that develop from brain tissue are rare, arising in 15,000 to 20,000 people in the U.S. every year, but they are extremely aggressive. According to Dr. Bruce, radiation and surgery may remove the initial mass, but the cancer comes back in nearly 100 percent of cases. Patients typically survive one to three years after diagnosis.
Other NewYork-Presbyterian/Columbia physicians involved in the study include Drs. Guy McKhann, Michael Sisti, Casi Balmaceda, Robert Fine, Joanne Loughlin, Charles Hesdorffer, Peter Canoll, Stephen Sands, Robert DeLaPaz, and Truman Brown.
Topotecan is manufactured by GlaxoSmithKline, of Conshohocken, Pennsylvania, and is sold under the trade name Hycamtin®.
Study participants must have a single, recurrent malignant glioma tumor under 100 cc in size located in the cerebral cortex and have already undergone standard surgical or radiological treatment. For more information, patients may contact Joanne Loughlin at 212-305-7056.
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