FORT WORTH, Texas -- Several parents of children battling a rare form of cancer turned to a clinical trial for help, but an NBC 5 investigation questions whether the study actually killed patients

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Child's Life In The Balance

After six months of investigation, NBC 5 News uncovered troubling information about the safety of the study being conducted at a half-dozen North Texas hospitals.

The trouble involves a side effect of the treatment that led to the deaths of four children in the study.

Travis Whitman was among them. When he began to get sick in the summer of 2001, his mother thought the little boy was suffering from allergies.

However, Elizabeth Whitman would soon learn from doctors that the child had a rare form of cancer called rabdomyosarcomma, an aggressive form of the disease that attacks the muscles and only affects children.

"They told me the odds were stacked against him for surviving," Whitman said.

Doctors suggested a worldwide pediatric drug trail to combat the cancer and Whitman enrolled Travis.

Doctors gave the boy three powerful chemotherapy drugs, but doctors began to notice the 4-year-old was unusually sick just three months into the study.

Whitman said her son was disoriented and incoherent. "We had to hold him down, and then that's when they found out that he was in liver failure."

Doctors diagnosed Travis with Veno Occlusive Disease, or VOD, a form of liver failure that can develop as a side effect of chemotherapy.

One month later, Travis was dead.

Months later, Whitman received an e-mail from the parents of Daniella Rogers, a St. Louis toddler diagnosed with the same rare form of cancer who had been a part of the same clinical trial in a hospital near St. Louis.

Doctor's say the 20-month-old also died from VOD.

While both families signed informed consent documents that mentioned liver failure, there were no specifics about VOD mentioned and no warning signs.

ON THE NET:

www.traviswhitman.com

www.daniellarogers.org

In July, NBC asked the National Institutes of Health, which funds the clinical study, to explain what doctors knew about the possibility of VOD and how many of the 300 patients had suffered from symptoms.

The institute suspended the trial 25 days later and the Office of Human Research Protection launched an investigation.

According to Dr. Gregory Reaman, the chairman of the children's oncology group running the test, there was no wrongdoing.

"There is no evidence that information was withheld," Reaman said.

However, Reaman admits that the children may have been given too much of the powerful chemotherapy drugs.

NBC 5 obtained a copy of a document announcing the suspension of the study. It cited 16 cases of VOD, four of which were fatal.

Whitman said she wouldn't file a lawsuit, despite pressure from others to do so, because neither money nor blame will bring back her son.

Instead, the grieving mother prefers to tell her story to honor Travis and caution other families considering experimental treatments.