Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003720
Status:
COMPLETED
Last Update Posted:
2012-08-23
First Post:
1999-11-01
Brief Title:
SU5416 in Treating Patients With AIDS-Related Kaposis Sarcoma
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Multicenter Dose Escalating Study in Patients With Cutaneous AIDS-Related Kaposis Sarcoma
Status:
COMPLETED
Status Verified Date:
2012-08
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 I trial to study the effectiveness of SU5416 in treating patients who have AIDS-related Kaposis sarcoma
PURPOSE Phase I trial to study the effectiveness of SU5416 in treating patients who have AIDS-related Kaposis sarcoma
Detailed Description:
OBJECTIVES I Evaluate the safety and tolerability of SU5416 in patients with AIDS-related Kaposis 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 patients
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 thereafter
PROJECTED ACCRUAL This study will accrue a maximum of 30 patients
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 thereafter
PROJECTED ACCRUAL This study will accrue a maximum of 30 patients
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 |
|---|---|---|---|
| LAC-USC-17K981 | None | None | None |
| CDR0000066829 | None | None | None |