Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006222
Status:
TERMINATED
Last Update Posted:
2013-06-03
First Post:
2000-09-11
Brief Title:
EMD 121974 in Treating Patients With HIV-Related Kaposis Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of EMD 121974 in Patients With HIV Related Kaposis Sarcoma
Status:
TERMINATED
Status Verified Date:
2001-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase I trial to study the effectiveness of EMD 121974 in treating patients who have HIV-related Kaposis sarcoma EMD 121974 may stop the growth of Kaposis sarcoma by stopping blood flow to the tumor
Detailed Description:
OBJECTIVES
I Determine the safety and toxicity of EMD 121974 in patients with HIV related Kaposis sarcoma
II Determine the antiangiogenic activity of this drug in these patients III Determine the antitumor activity of this drug in these patients IV Determine the effect of this drug on CD4 and CD8 cell counts and percentages and on HIV viral load in these patients
V Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a dose escalation study
Patients receive EMD 121974 IV twice a week for four weeks Courses repeat every 4 weeks in the absence of disease progression Cohorts of 3-6 patients receive escalating doses of EMD 121974 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities
Patients are followed for at least 1 month
PROJECTED ACCRUAL A total of 18-30 patients will be accrued for this study within 1 year
I Determine the safety and toxicity of EMD 121974 in patients with HIV related Kaposis sarcoma
II Determine the antiangiogenic activity of this drug in these patients III Determine the antitumor activity of this drug in these patients IV Determine the effect of this drug on CD4 and CD8 cell counts and percentages and on HIV viral load in these patients
V Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a dose escalation study
Patients receive EMD 121974 IV twice a week for four weeks Courses repeat every 4 weeks in the absence of disease progression Cohorts of 3-6 patients receive escalating doses of EMD 121974 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities
Patients are followed for at least 1 month
PROJECTED ACCRUAL A total of 18-30 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| CDR0000068142 | REGISTRY | PDQ Physician Data Query | None |
| AMC-023 | None | None | None |