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USF says its trial of gene therapy likely to resume


© St. Petersburg Times, published March 29, 2000

TAMPA -- The University of South Florida plans to reopen a gene therapy trial for terminal cancer patients after reviewing more information about the death of a patient in Arkansas who had the same treatment.

Dr. Richard Heller, chairman of USF's Institutional Biosafety Committee, said the committee voted on Tuesday to lift the suspension on the clinical trial after the therapy's developer, Vical Inc. of San Diego, provided more details about its safety and about the death of the patient in Arkansas.

The committee agreed the treatment is reasonably safe, but it also changed the patient consent form to reflect that it could, potentially, lead to death; it dropped a sentence that said no one had suffered any serious side effects from the drug, and it cut the word "remote" from a sentence explaining that death was a possible side effect.

The changes must be approved by USF's Institutional Review Board, which oversees all trials at the school, before the trial again can recruit patients, but Heller expects that to happen soon.

"They're not really significant changes, but they're changes that need to be made so that the correct information is relayed to the patient before they enroll in the study," Heller said.

The USF College of Medicine was the only one of about 40 participating centers to stop the trial after learning in January of the patient's death, which the lead researcher at the University of Arkansas had indicated was "probably" related to the gene therapy.

The trial involves a drug called Allovectin-7 and is being tested in patients around the United States who have severe forms of skin cancer, called melanoma, that have not responded to other treatments. It uses altered genes to help the body's immune system better target the cancer.

Fewer than 10 people have gotten injections of Allovectin at the H. Lee Moffitt Cancer Center and Research Institute at USF in Tampa, and none has suffered adverse affects, school officials said.

Vical said that USF overreacted by stopping the trial last month and that the therapy has been used safely in more than 500 patients.

Heller said the company has now provided data that show the Arkansas patient, who died about two months after the treatment, likely died from other causes.

Experimental gene therapy has come under scrutiny since the death last fall of teenager at the University of Pennsylvania.

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