A Phase I-II Trial Of BMS-275291 In Patients With HIV-Related Kaposi's Sarcoma
I. Determine whether the change in percent of apoptotic cells on tumor biopsies before and
after treatment with BMS-275291 is a valid endpoint in patients with HIV-related Kaposi's
II. Determine the safety and tolerability of this drug in these patients. III. Determine the
antitumor effects of this drug in these patients. IV. Determine the effect of this drug on
overall quality of life and tumor-specific symptoms in these patients.
V. Determine the effect of this drug on CD4 and CD8 cell counts and percentages and HIV
viral load in these patients.
VI. Determine the effect of this drug on human herpes virus-8 (HHV-8) viral load and
correlate HHV-8 viral burden, tumor stage, and prognosis in these patients.
VII. Determine the peak plasma concentration of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oral BMS-275291 1-2 times daily. Treatment repeats every 4 weeks in the
absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of BMS-275291 until the recommended phase II
dose (RPTD) is determined. The RPTD is the dose at which no more than 1 of 6 patients
experiences dose-limiting toxicity and more than 1 of 6 patients experiences clinical
response or at least 5 of 6 patients demonstrate biologic activity. An additional 29
patients are treated at the RPTD.
Quality of life is assessed on day 15 of the first course and then every 28 days thereafter.
Patients are followed for at least 1 month.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Jamie Hayden Von Roenn, MD
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University||Chicago, Illinois 60611|
|Herbert Irving Comprehensive Cancer Center||New York, New York 10032|