SU5416 in Treating Patients With AIDS-Related Kaposi's Sarcoma
RATIONALE: SU5416 may stop the growth of Kaposi's sarcoma by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have AIDS-related Kaposi's sarcoma.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Multicenter, Open-Label, Phase II Study of SU5416 in Patients With Cutaneous AIDS-Related Kaposi's Sarcoma|
|Study Start Date:||January 2000|
|Study Completion Date:||November 2000|
|Primary Completion Date:||November 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the antitumor effects of SU5416 in patients with chemotherapy refractory cutaneous AIDS-related Kaposi's sarcoma. II. Determine the safety and tolerability of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine the safety of this regimen on HIV replication and immune parameters in these patients. V. Determine the effects of this regimen on overall quality of life and tumor specific symptoms in these patients.
OUTLINE: This is a multicenter study. Patients receive SU5416 IV twice weekly for 4 weeks. Treatment continues for up to 1 year in the absence of disease progression or unacceptable toxicity. Quality of life is assessed. Patients are followed at 30 days after the last treatment, and every 3 months thereafter.
PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study within 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005042
|United States, California|
|UCLA Clinical AIDS Research and Education (CARE) Center|
|Los Angeles, California, United States, 90024|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Steven A. Miles, MD||UCLA Clinical AIDS Research and Education (CARE) Center|