Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002945
Status:
COMPLETED
Last Update Posted:
2012-04-13
First Post:
1999-11-01
Brief Title:
High Dose Chemotherapy Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Myeloid Leukemia
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
High-Dose Cytarabine and Idarubicin Induction High Dose Etoposide and Cyclophosphamide Intensification Autologous Stem Cell Transplantation and Interleukin-2 Immune Modulation in Previously Untreated De Novo and Secondary Adult Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2012-04
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 III trial to study the effectiveness of high-dose combination chemotherapy peripheral stem cell transplantation and interleukin-2 in treating patients who have acute myeloid leukemia
PURPOSE Phase III trial to study the effectiveness of high-dose combination chemotherapy peripheral stem cell transplantation and interleukin-2 in treating patients who have acute myeloid leukemia
Detailed Description:
OBJECTIVES
Determine relapse free survival of patients with previously untreated de novo or secondary acute myeloid leukemia treated with high dose cytarabine and idarubicin induction high dose etoposide and cyclophosphamide intensification filgrastim G-CSF melphalan radiotherapy autologous peripheral blood stem cell PBSC transplantation and interleukin-2
Correlate remission rate and relapse free survival with multidrug resistance phenotype in patients treated with this regimen
Determine stem cell content and presence of cells with leukemia specific markers in PBSC harvested following high dose etoposide and cyclophosphamide intensification
Correlate NK cell expansion an increase in both proportion and absolute number during interleukin-2 therapy following autologous PBSC transplantation with disease free survival
OUTLINE
Induction
Patients receive cytarabine IV over 1 hour every 12 hours for 6 days and idarubicin IV over 30 minutes following third fifth and seventh doses of cytarabine Beginning 12 hours after the last dose of cytarabine patients receive filgrastim G-CSF subcutaneously SQ each day until blood counts recover
Intensification
Patients receive etoposide IV over 343 hours followed 1 hour later by cyclophosphamide IV over 2 hours for 3 days Beginning 24 hours after the last dose of cyclophosphamide patients receive G-CSF SQ each day until blood counts recover
Peripheral blood stem cells PBSC are harvested and selected for CD34 cells Patients receive melphalan IV over 1 hour on day -4 followed by total body irradiation on days -3 -2 and -1 PBSC are reinfused on day 0
When blood counts recover patients receive high dose interleukin-2 SQ on days 1-10 followed by low dose interleukin-2 SQ on days 11-13 Interleukin-2 treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity Patients with immunologic response to 6 courses of interleukin-2 treatment may continue for 6 additional courses
PROJECTED ACCRUAL Approximately 100 patients will be accrued for this study over 5 years
Determine relapse free survival of patients with previously untreated de novo or secondary acute myeloid leukemia treated with high dose cytarabine and idarubicin induction high dose etoposide and cyclophosphamide intensification filgrastim G-CSF melphalan radiotherapy autologous peripheral blood stem cell PBSC transplantation and interleukin-2
Correlate remission rate and relapse free survival with multidrug resistance phenotype in patients treated with this regimen
Determine stem cell content and presence of cells with leukemia specific markers in PBSC harvested following high dose etoposide and cyclophosphamide intensification
Correlate NK cell expansion an increase in both proportion and absolute number during interleukin-2 therapy following autologous PBSC transplantation with disease free survival
OUTLINE
Induction
Patients receive cytarabine IV over 1 hour every 12 hours for 6 days and idarubicin IV over 30 minutes following third fifth and seventh doses of cytarabine Beginning 12 hours after the last dose of cytarabine patients receive filgrastim G-CSF subcutaneously SQ each day until blood counts recover
Intensification
Patients receive etoposide IV over 343 hours followed 1 hour later by cyclophosphamide IV over 2 hours for 3 days Beginning 24 hours after the last dose of cyclophosphamide patients receive G-CSF SQ each day until blood counts recover
Peripheral blood stem cells PBSC are harvested and selected for CD34 cells Patients receive melphalan IV over 1 hour on day -4 followed by total body irradiation on days -3 -2 and -1 PBSC are reinfused on day 0
When blood counts recover patients receive high dose interleukin-2 SQ on days 1-10 followed by low dose interleukin-2 SQ on days 11-13 Interleukin-2 treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity Patients with immunologic response to 6 courses of interleukin-2 treatment may continue for 6 additional courses
PROJECTED ACCRUAL Approximately 100 patients will be accrued for this study over 5 years
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-DS-96-48 | None | None | None |