DALLAS -- Oct. 16, 1997 -- Success in treating stubborn cancers with a drug that was shelved 50 years ago has encouraged the Food and Drug Administration (FDA) to provide a three-year, $447,534 grant to UT Southwestern Medical Center at Dallas to begin second-stage clinical tests of the drug, aminopterin.
Aminopterin is the "parent" of the commonly prescribed, cancer-fighting drug methotrexate. Originally tested in the 1940s, it fell out of favor with doctors because of concerns about toxicity and difficulties synthesizing it. In recent years, Dr. Barton Kamen, a professor of pediatrics and pharmacology at UT Southwestern, has taken a new look at the drug to see if it might prove effective in treating patients -- particularly children with leukemia -- whose cancer does not respond to methotrexate.
The pediatrician doesn't usually treat adults, but Ingrid Cofield, a 49-year-old woman from Rowlett, Texas, is glad he made an exception.
Cofield was one of several adults Kamen enrolled in a Phase I trial of the drug aminopterin last year.
Phase I trials usually are conducted to see what doses of drugs patients can tolerate. But the aminopterin made a tumor in Cofield's liver disappear.
"I didn't expect this at all," Cofield said. "I thought maybe it would become a little smaller, but not that it would all go away."
Cofield originally was diagnosed with endometrial cancer in 1993. She had a hysterectomy to remove her cancerous uterus and then went through chemotherapy. The cancer was gone for a year, but then she discovered a lump in her groin. Hormonal therapy prevented enlargement for a while, but the lump started growing again. She again underwent chemotherapy, but tests soon showed the tumor had spread to her liver.