Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009698
Status:
COMPLETED
Last Update Posted:
2013-06-28
First Post:
2001-02-02
Brief Title:
Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
IL-2 Infusion in AML Patients After Autologous Bone Marrow Transplant A Pediatric Oncology Group Wide Phase I Trial
Status:
COMPLETED
Status Verified Date:
2013-06
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 more cancer cells
PURPOSE Phase I trial to study the effectiveness of interleukin-2 in treating children who have undergone bone marrow transplantation for acute myeloid leukemia
PURPOSE Phase I trial to study the effectiveness of interleukin-2 in treating children who have undergone bone marrow transplantation for acute myeloid leukemia
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of interleukin-2 after autologous bone marrow transplantation in pediatric patients with acute myeloid leukemia II Determine toxic effects of this regimen in these patients
OUTLINE This is a dose escalation study Patients receive interleukin-2 IL-2 subcutaneously on days 1-7 9-14 and 16-22 On days 8 and 15 patients receive IL-2 IV over 2 hours Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity Cohorts of 6-9 patients receive escalating doses of IL-2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 9 patients experience dose-limiting toxicity Patients are followed every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 6-27 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive interleukin-2 IL-2 subcutaneously on days 1-7 9-14 and 16-22 On days 8 and 15 patients receive IL-2 IV over 2 hours Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity Cohorts of 6-9 patients receive escalating doses of IL-2 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 9 patients experience dose-limiting toxicity Patients are followed every 6 months for 4 years and then annually thereafter
PROJECTED ACCRUAL A total of 6-27 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 |
|---|---|---|---|
| CDR0000065574 | OTHER | Clinical Trialsgov | None |
| POG-9674 | OTHER | None | None |