A Multicenter, Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma
OBJECTIVES: I. Evaluate the safety and tolerability of SU5416 in patients with AIDS-related
Kaposi's sarcoma. II. Determine the pharmacokinetics of this regimen in these patients. III.
Evaluate the antitumor effects and biological activity of this regimen in these patients.
IV. Determine the safety of this regimen on HIV replication and immune parameters in these
OUTLINE: This is a dose escalation, multicenter study. Patients receive SU5416 by
intravenous injection twice weekly for 4 weeks. Patients may continue treatment for a
maximum of 1 year in the absence of disease progression and unacceptable toxicity. In the
absence of dose limiting toxicity (DLT) in the first 6 patients treated, subsequent cohorts
of 6 patients each receive escalating doses of SU5416 on the same schedule. If DLT occurs in
2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose
is declared the maximum tolerated dose (MTD). Six additional patients are treated at the
MTD. Patients are followed at 30 days after the last treatment, and every 3 months
PROJECTED ACCRUAL: This study will accrue a maximum of 30 patients.
Primary Purpose: Treatment
Alison L. Hannah, MBBS
United States: Food and Drug Administration
|Kaplan Cancer Center||New York, New York 10016|
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|
|USC/Norris Comprehensive Cancer Center||Los Angeles, California 90033-0800|
|St. Francis Hospital||San Francisco, California 94109|