Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003190
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without Valspodar in Treating Patients With Previously Untreated Acute Myeloid Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of MDR Modulation With PSC-833 NSC 648265 Followed by Immunotherapy With rIL-2 NSC 373364 vs No Further Therapy in Previously Untreated Patients With AML gt60 Years
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:
Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without PSC 833 followed by interleukin-2 or no further therapy in treating older patients who have acute myeloid leukemia Some cancers become resistant to chemotherapy drugs Combining PSC 833 with more than one chemotherapy drug may reduce resistance to the drugs and allow the cancer cells to be killed Combining interleukin-2 with combination chemotherapy plus PSC 833 may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine whether the addition of PSC-833 to induction chemotherapy improves complete response rates and whether the addition of PSC-833 to induction and consolidation chemotherapy improves survival for patients with AML 60 years
II To determine whether the administration of low-dose subcutaneous rIL-2 immunotherapy with intermittent high-dose boluses after chemotherapy prolongs disease-free survival
OUTLINE This is a partially randomized multicenter study Patients are stratified according to participating center and disease characteristics de novo acute myeloid leukemia AML versus AML with antecedent myelodysplasia Patients are randomized to one of two maintenance therapy arms
Arm I Patients receive cytarabine IV continuously over 7 days and daunorubicin IV bolus followed by etoposide IV over 2 hours on days 1-3
Arm II Patients receive treatment as in arm I with the addition of PSC 833 induction A loading dose of PSC 833 IV is given over 2 hours followed by a 74-hour continuous infusion of PSC 833 beginning 2 hours before daunorubicin and etoposide Patients may receive a second induction course if residual leukemia is present in the bone marrow Patients who experience a complete remission CR and meet certain other criteria receive postremission chemotherapy consisting of cytarabine IV continuously over 5 days plus daunorubicin IV followed by etoposide IV over 2 hours on days 1 and 2 Patients who are randomized to receive PSC 833 during induction chemotherapy receive a loading dose of PSC 833 before beginning a 48-hour continuous infusion of PSC 833 concurrently with cytarabinedaunorubicinetoposide postremission chemotherapy
After completing postremission chemotherapy patients are randomized to a no further treatment group or interleukin-2 IL-2 immunotherapy Treatment begins within 5 months of postremission chemotherapy IL-2 immunotherapy consists of low-dose subcutaneous SC IL-2 on days 1-14 19-28 33-42 47-56 61-70 and 75-90 and high-dose bolus SC IL-2 on days 15-17 29-31 43-45 57-59 and 71-73
Patients are followed every 2 months for 2 years every 6 months for 2 years annually until the tenth year and then at relapse
I To determine whether the addition of PSC-833 to induction chemotherapy improves complete response rates and whether the addition of PSC-833 to induction and consolidation chemotherapy improves survival for patients with AML 60 years
II To determine whether the administration of low-dose subcutaneous rIL-2 immunotherapy with intermittent high-dose boluses after chemotherapy prolongs disease-free survival
OUTLINE This is a partially randomized multicenter study Patients are stratified according to participating center and disease characteristics de novo acute myeloid leukemia AML versus AML with antecedent myelodysplasia Patients are randomized to one of two maintenance therapy arms
Arm I Patients receive cytarabine IV continuously over 7 days and daunorubicin IV bolus followed by etoposide IV over 2 hours on days 1-3
Arm II Patients receive treatment as in arm I with the addition of PSC 833 induction A loading dose of PSC 833 IV is given over 2 hours followed by a 74-hour continuous infusion of PSC 833 beginning 2 hours before daunorubicin and etoposide Patients may receive a second induction course if residual leukemia is present in the bone marrow Patients who experience a complete remission CR and meet certain other criteria receive postremission chemotherapy consisting of cytarabine IV continuously over 5 days plus daunorubicin IV followed by etoposide IV over 2 hours on days 1 and 2 Patients who are randomized to receive PSC 833 during induction chemotherapy receive a loading dose of PSC 833 before beginning a 48-hour continuous infusion of PSC 833 concurrently with cytarabinedaunorubicinetoposide postremission chemotherapy
After completing postremission chemotherapy patients are randomized to a no further treatment group or interleukin-2 IL-2 immunotherapy Treatment begins within 5 months of postremission chemotherapy IL-2 immunotherapy consists of low-dose subcutaneous SC IL-2 on days 1-14 19-28 33-42 47-56 61-70 and 75-90 and high-dose bolus SC IL-2 on days 15-17 29-31 43-45 57-59 and 71-73
Patients are followed every 2 months for 2 years every 6 months for 2 years annually until the tenth year and then at relapse
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 |
|---|---|---|---|
| U10CA031946 | NIH | None | httpsreporternihgovquickSearchU10CA031946 |
| CALGB-9720 | None | None | None |