"I've always been a fighter," said Cofield, who won the women's master's division of the 1988 and 1989 White Rock marathons. "They gave me a choice of going home and living what life I had left or trying the experimental treatment. I said, 'I'd try it.'"
Of the 20 patients who participated in the Phase I trial, three others also showed a positive response to the aminopterin: an 8-year-old boy with a nerve-sheath tumor, a 10-year-old boy with acute-myelogenous leukemia (AML) and a 4-year-old girl with a neuroectodermal tumor.
Kamen presented his findings to the American Society for Clinical Oncology (ASCO) in May.
"This is terrific news for the patients and terrific news for us," said Kamen, holder of the Carl B. and Florence E. King Foundation Distinguished Chair in Pediatric Oncology Research. "In the 20 years I've been doing this, I can't remember this many responses in a Phase I trial. This means we can be optimistic we have an effective drug."
The FDA-funded Phase II clinical trial of the drug is already under way. The first patient enrolled in the trial, which focuses on leukemia patients, is in complete remission.
Four other institutions are participating in the Phase II study: The University of Chicago Division of the Biological Sciences Pritzker School of Medicine, St. Jude Children's Research Hospital in Memphis, UT M.D. Anderson Cancer Center in Houston and UT Health Science Center at San Antonio.
Because of aminopterin's success in Cofield, doctors at UT Southwestern also are beginning a separate clinical trial of the drug on women with persistent or recurrent endometrial cancer.