Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005042
Status:
COMPLETED
Last Update Posted:
2014-08-29
First Post:
2000-04-06
Brief Title:
SU5416 in Treating Patients With AIDS-Related Kaposis Sarcoma
Sponsor:
AIDS Malignancy Consortium
Organization:
AIDS Malignancy Consortium
Study Overview
Official Title:
A Multicenter Open-Label Phase II Study of SU5416 in Patients With Cutaneous AIDS-Related Kaposis Sarcoma
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE SU5416 may stop the growth of Kaposis 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 Kaposis sarcoma
PURPOSE Phase II trial to study the effectiveness of SU5416 in treating patients who have AIDS-related Kaposis sarcoma
Detailed Description:
OBJECTIVES I Determine the antitumor effects of SU5416 in patients with chemotherapy refractory cutaneous AIDS-related Kaposis 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067633 | OTHER | NCI | None |