Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052897
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2003-01-24
Brief Title:
SGN-00101 in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial of SGN-00101 in the Treatment of High-Grade Anal Intraepithelial Neoplasia AIN in HIV-Positive Individuals
Status:
COMPLETED
Status Verified Date:
2004-04
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:
Phase III trial to study the effectiveness of SGN-00101 in preventing anal cancer in HIV-positive patients who have high-grade anal neoplasia Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer SGN-00101 may be effective in preventing anal cancer
Detailed Description:
OBJECTIVES
I Determine the safety and maximum tolerated dose of SGN-00101 in HIV-positive patients with high-grade anal squamous intraepithelial lesions
II Determine clinical response and histologiccytologic regression in patients treated with this drug
III Determine immune response in patients treated with this drug IV Determine the effect of this drug on HIV viral load and CD4 level in these patients
OUTLINE This is a dose-escalation study
Patients receive SGN-00101 subcutaneously once on weeks 0 4 and 8 Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 5-6 patients receive escalating doses of SGN-00101 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experience dose-limiting toxicity
Patients are followed at 1 4 and 10 months
I Determine the safety and maximum tolerated dose of SGN-00101 in HIV-positive patients with high-grade anal squamous intraepithelial lesions
II Determine clinical response and histologiccytologic regression in patients treated with this drug
III Determine immune response in patients treated with this drug IV Determine the effect of this drug on HIV viral load and CD4 level in these patients
OUTLINE This is a dose-escalation study
Patients receive SGN-00101 subcutaneously once on weeks 0 4 and 8 Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 5-6 patients receive escalating doses of SGN-00101 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experience dose-limiting toxicity
Patients are followed at 1 4 and 10 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 |
|---|---|---|---|
| CDR0000258786 | REGISTRY | PDQ Physician Data Query | None |
| AMC-035 | None | None | None |