Outpatient Treatment for Older Patients with AML
Name of the Trial
Phase II Randomized Study of Tipifarnib in Older Patients with Previously Untreated Acute Myeloid Leukemia (SWOG-S0432). See the protocol summary at http://cancer.gov/clinicaltrials/SWOG-S0432.
Dr. Harry Erba, Southwest Oncology Group; Richard Larson, Cancer and Leukemia Group B; and Dr. Martin Tallman, Eastern Cooperative Oncology Group.
Why Is This Trial Important?
Acute myeloid leukemia (AML) is the most common type of leukemia in American adults. This disease typically strikes older adults, a group that may be less able to tolerate the aggressive therapies that are currently used to treat AML, such as combination chemotherapy and stem cell transplantation. Consequently, doctors are searching for new treatment approaches for older patients with AML.
In this study, researchers are testing a new drug called tipifarnib (Zarnestra) to treat patients aged 70 or older who have AML and who are not eligible for standard treatment. Tipifarnib belongs to a class of drugs called farnesyltransferase inhibitors, which inhibit the biochemical signals that tell cancer cells to grow.
"In a previous clinical trial, about 20 percent of AML patients treated with tipifarnib achieved a complete response, and an additional 15 percent achieved partial response," said Dr. Erba. "Those who responded to tipifarnib experienced better survival rates.
"Tipifarnib has several advantages over standard treatments. It is administered orally, which allows patients to be treated in an outpatient setting, and it is generally well tolerated," added Dr. Erba. "We believe that this study represents a novel approach to treating AML in patients who are not eligible for or cannot tolerate standard treatments."
Who Can Join This Trial?
Researchers seek to enroll up to 296 patients aged 70 and over with AML who are not eligible for or who have declined standard treatment. See the full list of eligibility criteria for this trial at http://cancer.gov/clinicaltrials/SWOG-S0432.
Where Is This Trial Taking Place?
Multiple study sites in the United States and Canada are recruiting patients for this trial. See the list of study sites at http://cancer.gov/clinicaltrials/SWOG-S0432.
See the list of study contacts at http://cancer.gov/clinicaltrials/SWOG-S0432 or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.
An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.