Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020683
Status:
TERMINATED
Last Update Posted:
2018-10-18
First Post:
2001-07-11
Brief Title:
A Phase II Trial of COL-3 in Patients With HIV Related Kaposis Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of COL-3 in Patients With HIV Related Kaposis Sarcoma
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Cancer Therapy Evaluation Programs CTEPs termination of drug supply
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
COL-3 may stop the growth of cancer by stopping blood flow to the tumor Randomized phase II trial to compare the effectiveness of two different regimens of COL-3 in treating patients who have HIV-related Kaposis sarcoma
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the tumor response rate and response duration of treatment with Col-3 at two different dose levels- 50 mgday and 100 mgday in subjects with HIV related KS
II To evaluate the biologic activity of Col-3 by measuring percent apoptotic cells on tumor biopsies pre- and post-treatment
III To evaluate the effect of Col-3 on serum levels of MMP-2 and MMP-9
SECONDARY OBJECTIVES
I To determine the safety and toxicity of Col-3 at two different dose levels in HIV related KS
II To evaluate the effect of Col-3 on overall quality of life III To evaluate the relationship between clinical response and quantitative measures of KSHVHHV-8 and HIV viral load
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive low-dose oral COL-3 once daily
Arm II Patients receive high-dose oral COL-3 once daily
Treatment on both arms continues in the absence of disease progression or unacceptable toxicity Quality of life is assessed
Patients are followed for at least 1 month
PROJECTED ACCRUAL A total of 70 patients 35 per treatment arm will be accrued for this study within 175 years
I To evaluate the tumor response rate and response duration of treatment with Col-3 at two different dose levels- 50 mgday and 100 mgday in subjects with HIV related KS
II To evaluate the biologic activity of Col-3 by measuring percent apoptotic cells on tumor biopsies pre- and post-treatment
III To evaluate the effect of Col-3 on serum levels of MMP-2 and MMP-9
SECONDARY OBJECTIVES
I To determine the safety and toxicity of Col-3 at two different dose levels in HIV related KS
II To evaluate the effect of Col-3 on overall quality of life III To evaluate the relationship between clinical response and quantitative measures of KSHVHHV-8 and HIV viral load
OUTLINE This is a randomized open-label multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive low-dose oral COL-3 once daily
Arm II Patients receive high-dose oral COL-3 once daily
Treatment on both arms continues in the absence of disease progression or unacceptable toxicity Quality of life is assessed
Patients are followed for at least 1 month
PROJECTED ACCRUAL A total of 70 patients 35 per treatment arm will be accrued for this study within 175 years
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 |
|---|---|---|---|
| U01CA070019 | NIH | CTEP | httpsreporternihgovquickSearchU01CA070019 |
| NCI-2012-02924 | REGISTRY | None | None |
| CDR0000068703 | None | None | None |
| AMC-027 | OTHER | None | None |
| AMC-027 | OTHER | None | None |