Cancer study participant concerned about vaccine effect on baby

<br>OKMULGEE, Okla. (AP) _ A woman who participated in a melanoma study conducted at the University of Oklahoma College of Medicine fears her newborn child could suffer side effects from her cancer treatment.

Saturday, October 14th 2000, 12:00 am

By: News On 6

OKMULGEE, Okla. (AP) _ A woman who participated in a melanoma study conducted at the University of Oklahoma College of Medicine fears her newborn child could suffer side effects from her cancer treatment.

Dawanna Robertson told the Tulsa World she believes she was not fully informed about the possible side effects of the vaccine or Granulocyte Marcrophage-Colony Stimulating Factor, or GM-CSF, which was administered during the study.

After learning she was pregnant with their third child, Robertson and her husband, Stephen, agreed she would continue the melanoma vaccine on advice from the medical school in Tulsa that the ``risks were minimal,'' Robertson said.

In addition to Tulsa, the vaccine was administered at sites in Bloomington, Ind., Springfield, Mo., Newport Beach, Calif., and Nashville and Knoxville, Tenn.

Robertson was involved in the study from January to August 1999. She gave birth to an 8-pound, 11-ounce girl on Jan. 30.

``She appears to be developing OK, but it also seems like her immune system is weaker than our other children,'' Robertson said. ``I just hope damage wasn't done that will show up later.''

The girl, named Sydney, was born two weeks premature. As a precaution, delivery room doctors removed and analyzed a small red skin blemish on her left knee that proved to be benign, Robertson said.

Robertson was diagnosed with malignant melanoma in 1997 after noticing changes in a mole on her left leg. After surgery to remove the mole and the melanoma's invasion into her lymph nodes, Robertson attempted treatment with interferon before finding the study involving an experimental vaccine.

The U.S. Food and Drug Administration barred expectant mothers from participating, saying ``potential effects of these drugs on the growing fetus are not known but may include serious birth defects.'' A consent form, which participants were given beforehand, said, ``If you are pregnant, you cannot take part in this study.''

But pregnant women diagnosed with melanoma and wanting to participate could possibly do so if granted a review by the FDA and Oklahoma's Institutional Review Board, said Gary Raskob, associate vice president of clinical research at the university's Health Science Center.

The review board in charge of research projects in Tulsa was disbanded after the study was discontinued earlier this year. An FDA audit revealed almost 60 deficiencies involving the manufacturing and dispensing of the vaccine. Ninety-eight people participated in the study.

In August, FDA officials agreed to allow a handful of melanoma sufferers who had participated in the study to receive melanoma vaccine shots until the supply is gone.

Raskob said as many as three pregnant women who signed consent forms after being briefed about the possible side effects of the vaccine on an unborn child were approved for the study or continued it after realizing they were pregnant.

Clinical data on the women and their children were not available because of privacy issues.

Lynn Mattson, a Tulsa attorney representing Dr. J. Michael McGee, who conducted the study, said records will show that Robertson was briefed properly on the possible side effects of the drug.

Robertson was given a 70 percent chance of survival for three years if she participated in some kind of chemotherapy program, she said.

She celebrated her third year in June but has not been examined for cancer in about a year.

``I am living with not dying with cancer,'' she said. ``I know the seriousness of this disease. I'm not in denial about it, but I am not going to stop living.''