Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450320
Status:
COMPLETED
Last Update Posted:
2014-08-29
First Post:
2007-03-20
Brief Title:
Sirolimus in Treating Patients With HIV-Related Kaposis Sarcoma
Sponsor:
AIDS Malignancy Consortium
Organization:
AIDS Malignancy Consortium
Study Overview
Official Title:
A Pilot Study of Rapamycin in Patients With HIV-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 Drugs used in chemotherapy such as sirolimus work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Sirolimus also may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
PURPOSE This pilot study is studying sirolimus in treating patients with HIV-related Kaposis sarcoma
PURPOSE This pilot study is studying sirolimus in treating patients with HIV-related Kaposis sarcoma
Detailed Description:
OBJECTIVES
Primary
Determine the safety and toxicity of sirolimus in patients with HIV-related Kaposis sarcoma KS receiving protease inhibitor PI-based or nonnucleoside reverse transcriptase inhibitor NNRTI-based highly active antiretroviral treatment HAART regimens
Estimate the doses of this drug required to achieve target trough sirolimus plasma concentrations of 5-10 ngmL in patients receiving PI-based or NNRTI-based HAART regimens
Secondary
Evaluate the clinical response of KS in patients treated with this sirolimus
Determine the effects of this drug on mTOR-dependent signaling in peripheral blood mononuclear cells PBMC and KS tumor biopsies
Determine the serum cytokine profiles pre- and post-treatment with this drug
Determine the effects of this drug on HIV and KS-associated herpesvirus KSHV viral loads
Determine the effects of this drug on T-lymphocyte subsets
OUTLINE This is a multicenter study Patients are assigned to 1 of 3 treatment groups
Group 1 patients receiving PI-based HAART regimen with ritonavir Patients receive oral sirolimus 00015 mgkgday once daily on days 1-28 for 6 courses as long as KS is stable or the disease is continuing to respond to treatment Patients may receive 6 additional courses provided they meet criteria for response in the absence of disease progression or unacceptable toxicity Patients with no more than stable disease after 6 courses are discontinued from treatment
Group 2 patients receiving PI-based HAART regimen without ritonavir Patients receive oral sirolimus 0003 mgkgday as in group 1
Group 3 patients receiving NNRTI-based HAART regimen Patients receive oral sirolimus 005 mgkgday as in group 1
Blood samples are collected periodically and analyzed for sirolimus levels via LCMSMS
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
Primary
Determine the safety and toxicity of sirolimus in patients with HIV-related Kaposis sarcoma KS receiving protease inhibitor PI-based or nonnucleoside reverse transcriptase inhibitor NNRTI-based highly active antiretroviral treatment HAART regimens
Estimate the doses of this drug required to achieve target trough sirolimus plasma concentrations of 5-10 ngmL in patients receiving PI-based or NNRTI-based HAART regimens
Secondary
Evaluate the clinical response of KS in patients treated with this sirolimus
Determine the effects of this drug on mTOR-dependent signaling in peripheral blood mononuclear cells PBMC and KS tumor biopsies
Determine the serum cytokine profiles pre- and post-treatment with this drug
Determine the effects of this drug on HIV and KS-associated herpesvirus KSHV viral loads
Determine the effects of this drug on T-lymphocyte subsets
OUTLINE This is a multicenter study Patients are assigned to 1 of 3 treatment groups
Group 1 patients receiving PI-based HAART regimen with ritonavir Patients receive oral sirolimus 00015 mgkgday once daily on days 1-28 for 6 courses as long as KS is stable or the disease is continuing to respond to treatment Patients may receive 6 additional courses provided they meet criteria for response in the absence of disease progression or unacceptable toxicity Patients with no more than stable disease after 6 courses are discontinued from treatment
Group 2 patients receiving PI-based HAART regimen without ritonavir Patients receive oral sirolimus 0003 mgkgday as in group 1
Group 3 patients receiving NNRTI-based HAART regimen Patients receive oral sirolimus 005 mgkgday as in group 1
Blood samples are collected periodically and analyzed for sirolimus levels via LCMSMS
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
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 |
|---|---|---|---|
| WYETH-0468X-4420 | OTHER | Wyeth | httpsreporternihgovquickSearchU01CA070019 |
| U01CA070019 | NIH | None | None |
| CDR0000536481 | OTHER | None | None |