Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075777
Status:
COMPLETED
Last Update Posted:
2014-08-29
First Post:
2004-01-09
Brief Title:
Valproic Acid in Treating Patients With Kaposis Sarcoma
Sponsor:
AIDS Malignancy Consortium
Organization:
AIDS Malignancy Consortium
Study Overview
Official Title:
A Pilot Trial Of Valproic Acid In Patients With 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 Valproic acid may help stop the growth of Kaposis sarcoma cells by blocking the enzymes necessary for tumor cell growth
PURPOSE This clinical trial is studying valproic acid in treating patients with HIV-related Kaposis sarcoma
PURPOSE This clinical trial is studying valproic acid in treating patients with HIV-related Kaposis sarcoma
Detailed Description:
OBJECTIVES
Primary
Determine the safety of valproic acid in patients with Kaposis sarcoma
Determine the effects of this drug on human herpes virus 8 KSHV gene expression using polymerase chain reaction and immunohistochemistry in these patients
Secondary
Determine the effects of this drug on HIV KSHV and Epstein-Barr virus viral loads in the plasma and peripheral blood mononuclear cells of these patients
Determine clinical response in patients treated with this drug
OUTLINE This is an open-label pilot multicenter study
Patients receive oral valproic acid twice daily on days 1-28 followed by a drug taper over 2 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed monthly for 6 months
PROJECTED ACCRUAL A total of 15-30 patients will be accrued for this study within 1 year
Primary
Determine the safety of valproic acid in patients with Kaposis sarcoma
Determine the effects of this drug on human herpes virus 8 KSHV gene expression using polymerase chain reaction and immunohistochemistry in these patients
Secondary
Determine the effects of this drug on HIV KSHV and Epstein-Barr virus viral loads in the plasma and peripheral blood mononuclear cells of these patients
Determine clinical response in patients treated with this drug
OUTLINE This is an open-label pilot multicenter study
Patients receive oral valproic acid twice daily on days 1-28 followed by a drug taper over 2 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed monthly for 6 months
PROJECTED ACCRUAL A total of 15-30 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 |
|---|---|---|---|
| CDR0000349348 | OTHER | NCI | httpsreporternihgovquickSearchU01CA070019 |
| U01CA070019 | NIH | None | None |