Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003875
Status:
COMPLETED
Last Update Posted:
2017-06-05
First Post:
1999-11-01
Brief Title:
Busulfan and Etoposide Followed by Peripheral Blood Stem Cell Transplant and Low-Dose Aldesleukin in Treating Patients With Acute Myeloid Leukemia
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Treatment of Acute Myelogenous Leukemia With Busulfan and Etoposide Followed by Autologous or Syngeneic Stem Cell Rescue and Low-Dose Interleukin 2 IL-2 Immunotherapy
Status:
COMPLETED
Status Verified Date:
2017-05
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:
This phase II trial studies the side effects and how well giving busulfan and etoposide followed by peripheral blood stem cell transplant PBSCT and low-dose aldesleukin works in treating patients with acute myeloid leukemia AML Drugs used in chemotherapy such as busulfan and etoposide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing A PBSCT may be able to replace blood-forming cells that were destroyed by chemotherapy This may allow more chemotherapy to be given so that more cancer cells are killed Aldesleukin may stimulate the white blood cells to kill cancer cells Giving busulfan and etoposide together followed by PBSCT and aldesleukin may be an effective treatment for AML
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the toxicity and overall survival of high dose Bu busulfanVP-16 etoposide followed by post-transplant low-dose interleukin IL-2 aldesleukin in patients with AML
SECONDARY OBJECTIVES
I To estimate the rate of relapse associated with this regimen
OUTLINE
PREPARATIVE REGIMEN Patients receive busulfan intravenously IV over 2 hours or orally PO every 6 hours on days -7 to -4 and etoposide IV on day -3
STEM CELL INFUSION Patients undergo autologous or syngeneic PBSC rescue on day 0
POST-TRANSPLANT ALDESLEUKIN THERAPY Beginning 30-100 days after transplant patients receive low-dose aldesleukin subcutaneously SC daily for 12 weeks
After completion of study treatment patients are followed up every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I To evaluate the toxicity and overall survival of high dose Bu busulfanVP-16 etoposide followed by post-transplant low-dose interleukin IL-2 aldesleukin in patients with AML
SECONDARY OBJECTIVES
I To estimate the rate of relapse associated with this regimen
OUTLINE
PREPARATIVE REGIMEN Patients receive busulfan intravenously IV over 2 hours or orally PO every 6 hours on days -7 to -4 and etoposide IV on day -3
STEM CELL INFUSION Patients undergo autologous or syngeneic PBSC rescue on day 0
POST-TRANSPLANT ALDESLEUKIN THERAPY Beginning 30-100 days after transplant patients receive low-dose aldesleukin subcutaneously SC daily for 12 weeks
After completion of study treatment patients are followed up every 3 months for 2 years every 6 months for 3 years and then annually thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| NCI-2011-00439 | REGISTRY | None | None |
| 131500 | OTHER | None | None |
| P30CA015704 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |