A Phase I Study of TNP-470 in the Treatment of AIDS-Associated Kaposi's Sarcoma
Since evidence shows that neovascularization is important in the development of Kaposi's
sarcoma, drugs that inhibit angiogenesis, such as TNP-470, may be of benefit in patients
with the disease.
Patients are entered at 7 escalating dose levels of TNP-470. (PER AMENDMENT 9/3/96: dose
maximum level changed.) Four patients treated at a given dose level must receive at least 4
weeks of therapy before escalation in subsequent cohorts proceeds. If 50 percent of patients
at a given dose level experience dose-limiting toxicity, the previous dose is defined as the
MTD and an additional two patients are treated at the MTD. Patients receive treatment for 12
weeks, followed by 2 weeks of rest, followed by an additional 12 weeks of treatment.
Patients are followed for 12 weeks post-treatment.
Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment
United States: Federal Government
|USC CRS||Los Angeles, California 90033|
|Northwestern University CRS||Chicago, Illinois 60611|
|Beth Israel Deaconess - East Campus A0102 CRS||Boston, Massachusetts 02215|
|Bmc Actg Crs||Boston, Massachusetts 02118|
|Washington U CRS||St. Louis, Missouri|
|Beth Israel Med. Ctr. (Mt. Sinai)||New York, New York 10003|