Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058045
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2003-04-07
Brief Title:
Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase I Study Of Low-Dose Subcutaneous Interleukin 2 IL-2 And Stem Cell Factor r-metHuSCF For Patients With AIDS And AIDS-Associated Malignancy
Status:
COMPLETED
Status Verified Date:
2013-01
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 Interleukin-2 may stimulate a persons white blood cells to kill cancer cells Stem cell factor may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of cancer therapy
PURPOSE Phase I trial to study the effectiveness of combining interleukin-2 with stem cell factor in treating patients who have AIDS or AIDS-related cancer
PURPOSE Phase I trial to study the effectiveness of combining interleukin-2 with stem cell factor in treating patients who have AIDS or AIDS-related cancer
Detailed Description:
OBJECTIVES
Determine the safety and toxicity of low-dose interleukin-2 and stem cell factor in patients with AIDS or AIDS-related malignancies
Determine the immune status of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of stem cell factor
Patients receive interleukin-2 IL-2 subcutaneously SC six days a week and stem cell factor SC three times a week for 8 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of stem cell factor until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional cohort of 3 patients receives treatment at the MTD
Patients are followed every 2 weeks for 1 month
PROJECTED ACCRUAL A total of 3-18 patients will be accrued for this study
Determine the safety and toxicity of low-dose interleukin-2 and stem cell factor in patients with AIDS or AIDS-related malignancies
Determine the immune status of patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of stem cell factor
Patients receive interleukin-2 IL-2 subcutaneously SC six days a week and stem cell factor SC three times a week for 8 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of stem cell factor until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional cohort of 3 patients receives treatment at the MTD
Patients are followed every 2 weeks for 1 month
PROJECTED ACCRUAL A total of 3-18 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 |
|---|---|---|---|
| RPCI-RP-9911 | None | None | None |