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June 25, 1998


UPCI combines gene therapy, chemotherapy in cancer trial More than half of all cancers arise when normal cells lose a gene that prevents them from turning into life-threatening tumor cells. Doctors at the University of Pittsburgh Cancer Institute (UPCI) are exploring a new experimental therapy in which they transfer this tumor-suppressing gene (p53) into patients to reverse a cancer's destructive course.

UPCI clinical investigators have opened the first nationwide clinical trial using p53 gene therapy together with chemotherapy for patients with advanced head and neck cancer. Plans also are underway at UPCI to begin studies of p53 gene therapy in patients with advanced primary liver cancer.

The therapy is based on the widely studied p53 gene, whose protein, p53, regulates cell growth. UPCI investigators are using a normal functioning p53 gene that has been packaged inside a harmless virus which enters cells but does not reproduce and spread throughout the body. This complex is directly injected into patients' tumors.

"In our clinical protocols, we are delivering a good version of the p53 gene so that the normal p53 protein will be produced to inhibit the growth of a patient's tumor," said Sanjiv Agarwala, assistant professor of medicine and principal investigator for the p53 head and neck cancer studies. Previous research has shown that when normal p53 genes are added to cultures of growing cancer cells or to tumors in living animals, the cancer cells die.

In the UPCI trial for head and neck cancer, p53 gene therapy will be combined with the chemotherapy drug, carboplatin and paclitaxel (Taxol). UPCI physicians also expect to apply p53 gene therapy to breast cancer, prostate cancer and melanoma.

In related pre-clinical research, UPCI scientist Albert DeLeo is incorporating parts of the p53 protein in a vaccine designed to prevent development of cancer. DeLeo, an associate professor in the School of Medicine's pathology department, is an expert in the molecular biology of p53.


Providing health benefits to children is cost effective, researchers say

Pitt researchers monitored children enrolled in free or low-cost health insurance programs in western Pennsylvania for a year and report that after enrolling, children were able to get the medical care they needed and also could freely participate in field trips, sports and other activities that require health insurance coverage.

The findings were published in the June 10 Journal of the American Medical Association.

"I was not surprised to find that having insurance decreased delays in receiving necessary care and also decreased unmet medical needs. However, I was surprised to realize the extent to which families are burdened by not having insurance," said Judith R. Lave, professor of health economics at the Graduate School of Public Health.

In a survey of parents of uninsured children, 73.5 percent reported being worried, scared or stressed out because their children lacked medical coverage.

Pitt researchers interviewed parents of 1,031 children at the time of enrollment into either the BlueCHIP Program or the Caring Program, both of which are administered by the Western Pennsylvania Caring Foundation and provide free or low-cost health insurance for working, lower-income families.

Lave and her colleagues reported that a year after enrolling, 99 percent of the children had a primary care physician, up from 89 percent at enrollment. The number of children getting routine dental treatment jumped by 25 percent. Also, visits to hospital emergency rooms decreased.

More than 10 million children in the United States lack health insurance. Many come from families that earn too much to qualify for Medicaid but not enough to buy their own health insurance. The federal government established the State Children's Health Insurance Program to help provide coverage to these children.

U.S. Health and Human Services Secretary Donna E. Shalala has approved Pennsylvania's plan to expand its Children's Health Insurance Program, providing up to $117 million annually in new federal funds.


UPCI part of multicenter trial of Herceptin The University of Pittsburgh Cancer Institute (UPCI) is participating in a multicenter study of Herceptin, a drug used to fight breast cancer cells with an excess of HER2 receptors.

About 30 percent of metastatic breast cancers are characterized by an excess of HER2, which triggers a more aggressive growth of cancer cells than cancers without HER2.

"The primary objective of this research study is to provide access to Herceptin to patients with an excess of HER2 metastatic breast cancer who have progressive disease and who already have undergone two chemotherapy regimens. The study also characterizes the safety of Herceptin alone or in combination with chemotherapy or hormonal treatment," said Adam Brufsky, principal investigator and a Pitt assistant professor of medicine.

This spring, at a meeting of the American Society of Clinical Oncology, researchers reported that Herceptin may prove beneficial if given to women early in the course of the disease.

The drug has virtually no side effects beyond chills and transient fever, compared to those typical of chemotherapy, which include hair loss, vomiting and nausea.

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