Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008190
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2001-01-06
Brief Title:
Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
High Dose Chemotherapy And Autologous Peripheral Blood Stem Cell Rescue For High Risk Acute Leukemia
Status:
COMPLETED
Status Verified Date:
2004-04
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 use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells Interleukin-2 may stimulate a persons white blood cells to kill leukemia cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation and interleukin-2 in treating patients who have acute leukemia
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation and interleukin-2 in treating patients who have acute leukemia
Detailed Description:
OBJECTIVES
Determine the efficacy of busulfan cyclophosphamide and etoposide followed by autologous peripheral blood stem cell transplantation and interleukin-2 in patients with high-risk acute leukemia
Determine the efficacy of immunomodulatory therapies in terms of relapse-free survival of these patients treated with this regimen
Determine the hematopoietic reconstitution relapse and survival of these patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE Following a course of mobilization chemotherapy patients receive priming therapy comprising filgrastim G-CSF and interleukin-2 through the completion of leukapheresis Patients then receive oral busulfan 4 times daily on days -8 through -5 cyclophosphamide IV continuously on days -4 and -3 and etoposide IV over 2 hours on day -4 For patients unable to receive cyclophosphamide and etoposide melphalan IV is administered instead on days -3 and -2 Autologous peripheral blood stem cells PBSC are reinfused on day 0
Patients then receive G-CSF daily beginning on day 0 and continuing until blood counts recover followed by interleukin-2 subcutaneously daily beginning at the completion of G-CSF therapy and continuing for 6 months
Patients are followed weekly for 1 month and then monthly thereafter
PROJECTED ACCRUAL A total of 19-25 patients will be accrued for this study within 3-5 years
Determine the efficacy of busulfan cyclophosphamide and etoposide followed by autologous peripheral blood stem cell transplantation and interleukin-2 in patients with high-risk acute leukemia
Determine the efficacy of immunomodulatory therapies in terms of relapse-free survival of these patients treated with this regimen
Determine the hematopoietic reconstitution relapse and survival of these patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE Following a course of mobilization chemotherapy patients receive priming therapy comprising filgrastim G-CSF and interleukin-2 through the completion of leukapheresis Patients then receive oral busulfan 4 times daily on days -8 through -5 cyclophosphamide IV continuously on days -4 and -3 and etoposide IV over 2 hours on day -4 For patients unable to receive cyclophosphamide and etoposide melphalan IV is administered instead on days -3 and -2 Autologous peripheral blood stem cells PBSC are reinfused on day 0
Patients then receive G-CSF daily beginning on day 0 and continuing until blood counts recover followed by interleukin-2 subcutaneously daily beginning at the completion of G-CSF therapy and continuing for 6 months
Patients are followed weekly for 1 month and then monthly thereafter
PROJECTED ACCRUAL A total of 19-25 patients will be accrued for this study within 3-5 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-G00-1889 | None | None | None |
| CPMC-IRB-8872 | None | None | None |
| CPMC-CAMP-27 | None | None | None |