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St. Jude says gene therapy experiment not tainted
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In this story: Trials closed pending results Concern first raised last year RELATED STORIES, SITES 
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MEMPHIS, Tennessee (CNN) -- St. Jude Children's Research Hospital says tests by the Food and Drug Administration show a vaccine used in a gene therapy experiment there contained no trace of the viruses that cause AIDS or the liver disease hepatitis C.
The FDA did not immediately return a call seeking confirmation of the report.
Additional tests conducted by the hospital's own laboratory also came back negative, according to a statement released by the hospital on Thursday.
St. Jude had said on February 11 that the viruses may have contaminated an experimental cancer vaccine used in two young brain cancer patients.
The patients in the study were children suffering from relapsed neuroblastoma, a terminal brain cancer.
St. Jude's statement Thursday said, "As earlier tests indicated, the comprehensive independent tests confirmed patients on the relapsed neuroblastoma study were never exposed to contaminated materials."
Trials closed pending results
Before the February 11 announcement, a similar vaccine was also used on six children at Baylor College of Medicine in Houston, two of whom later died of cancer. Officials there said pre-tests showed no evidence of contamination.
FDA officials said at the time that suggestions any of the children were exposed to HIV were highly questionable.
Last week's announcement prompted both hospitals to close their gene therapy trials to new patients, pending the FDA test results.
Hospital officials also delayed telling the families of those treated for possible infection. Doctors said they did not want to raise unnecessary concern.
The FDA called suggestions of possible initial contamination so tenuous that it would not have alarmed the children's families by telling them until ongoing tests settled the issue.
Questions raised last year
Questions about the safety of the experiments were raised last year as the Memphis research center was checking the quality of its gene therapy program.
St. Jude's lead investigator Dr. Laura Bowman said she checked the fluid in which viruses used in the experiment were grown. The fluid, called seed stock, was received by the laboratory in 1995. But Bowman said it was not until last year that she discovered it had never been tested for use in humans.
When the testing lapse was discovered and the seed stock finally was tested for impurities, the results indicated it contained a genetic marker for HIV, and for HCV, a virus that causes a form of hepatitis, Bowman said. A second test also yielded positive results.
However, results from both tests, Bowman said, were "very, very, very, very iffy." It could be that the positive results from both tests were "false positives," she said.
Neuroblastoma is "one of the most devastating childhood cancers," Bowman said. "Which is why these kinds of therapies are so important." She called the vaccine test "very promising."Medical Correspondent Eileen O'Connor and The Associated Press contributed to this report.
RELATED STORIES:
Gene tests may have exposed kids to HIV, hepatitis virus
February 12, 2000
FDA to defend closure of gene therapy trials to Senate subcommittee
February 2, 2000
FDA suspends trials at gene-therapy lab
January 22, 2000
RELATED SITES:
St. Jude Children's Research Hospital -- Home Page
Food and Drug Administration Home Page
Neuroblastoma Resources
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