Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020449
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2001-07-11
Brief Title:
Liposomal Doxorubicin and Interleukin-12 in Treating Patients With AIDS-Related Kaposis Sarcoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Liposomal Doxorubicin and Interleukin-12 in AIDS-Associated Kaposis Sarcoma Followed by Chronic Administration of Interleukin-12
Status:
COMPLETED
Status Verified Date:
2004-03
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 work in different ways to stop tumor cells from dividing so they stop growing or die Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a persons white blood cells to kill the tumor cells Combining chemotherapy with interleukin-12 may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining liposomal doxorubicin with interleukin-12 in treating patients who have AIDS-related Kaposis sarcoma
PURPOSE Phase II trial to study the effectiveness of combining liposomal doxorubicin with interleukin-12 in treating patients who have AIDS-related Kaposis sarcoma
Detailed Description:
OBJECTIVES
Determine the overall response rate in patients with AIDS-associated Kaposis sarcoma KS treated with doxorubicin HCl liposome and interleukin-12
Determine the time to response and the number of complete responses in patients treated with this regimen
Determine the progression-free survival of patients treated with this regimen
Provide pilot information on the ability of interleukin-12 to maintain major responses induced with paclitaxel salvage therapy in patients with aggressive or life-threatening KS after treatment failure with doxorubicin HCl liposome and interleukin-12
Determine the effect of this regimen on CD4 counts and viral load in these patients
OUTLINE Patients receive doxorubicin HCl liposome LipoDox IV over 30 minutes once every 3 weeks for a total of 6 doses Beginning concurrently with the initiation of LipoDox patients also receive interleukin-12 IL-12 subcutaneously twice weekly at least 3 days apart for up to 3 years
Patients with refractory disease are transferred to the paclitaxel salvage therapy regimen comprising paclitaxel IV continuously on days 1-4 once every 3 weeks until a major response is achieved Beginning concurrently with the initiation of paclitaxel salvage therapy patients also receive IL-12 as above for up to 3 years
Treatment continues in the absence of disease progression or unacceptable toxicity Patients achieving a complete response may discontinue IL-12 administration If necessary IL-12 treatment may resume at a later time
Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 24-36 patients will be accrued for this study within 2-4 years
Determine the overall response rate in patients with AIDS-associated Kaposis sarcoma KS treated with doxorubicin HCl liposome and interleukin-12
Determine the time to response and the number of complete responses in patients treated with this regimen
Determine the progression-free survival of patients treated with this regimen
Provide pilot information on the ability of interleukin-12 to maintain major responses induced with paclitaxel salvage therapy in patients with aggressive or life-threatening KS after treatment failure with doxorubicin HCl liposome and interleukin-12
Determine the effect of this regimen on CD4 counts and viral load in these patients
OUTLINE Patients receive doxorubicin HCl liposome LipoDox IV over 30 minutes once every 3 weeks for a total of 6 doses Beginning concurrently with the initiation of LipoDox patients also receive interleukin-12 IL-12 subcutaneously twice weekly at least 3 days apart for up to 3 years
Patients with refractory disease are transferred to the paclitaxel salvage therapy regimen comprising paclitaxel IV continuously on days 1-4 once every 3 weeks until a major response is achieved Beginning concurrently with the initiation of paclitaxel salvage therapy patients also receive IL-12 as above for up to 3 years
Treatment continues in the absence of disease progression or unacceptable toxicity Patients achieving a complete response may discontinue IL-12 administration If necessary IL-12 treatment may resume at a later time
Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 24-36 patients will be accrued for this study within 2-4 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-4010 | None | None | None |
| NCI-01-C-0067 | None | None | None |