Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004217
Status:
COMPLETED
Last Update Posted:
2015-03-06
First Post:
2000-01-28
Brief Title:
S9918 PSC 833 Daunorubicin and Cytarabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Phase II Study of Daunomycin and ARA-C Given by Continuous IV Infusion With PSC-833 for Previously Untreated Non-M3 Acute Myeloid Leukemia AML in Patients of Age 56 or Older
Status:
COMPLETED
Status Verified Date:
2015-03
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 PSC 833 may help chemotherapy drugs kill more cancer cells by making them more sensitive to the drugs
PURPOSE Phase II trial to study the effectiveness of PSC 833 daunorubicin and cytarabine in treating older patients who have newly diagnosed acute myeloid leukemia
PURPOSE Phase II trial to study the effectiveness of PSC 833 daunorubicin and cytarabine in treating older patients who have newly diagnosed acute myeloid leukemia
Detailed Description:
OBJECTIVES I Determine the safety and efficacy of daunorubicin and cytarabine by continuous infusion and PSC 833 in patients over age 56 with newly diagnosed acute myeloid leukemia II Determine the frequency and severity of toxicities of this regimen in these patients III Determine the frequency and prognosis of functional and phenotypic P-glycoprotein expression cytogenetics and pharmacokinetics in this population
OUTLINE This is a multicenter study Patients receive induction chemotherapy consisting of PSC 833 IV over 2 hours on day 1 then continuously for 96 hours daunorubicin IV continuously on days 1-3 and cytarabine IV continuously on days 1-7 Filgrastim G-CSF or sargramostim GM-CSF is administered subcutaneously SQ or IV beginning on day 15 and continuing until blood counts recover or day 21 If patients do not achieve complete remission after one course a second course is administered Patients who achieve A1 bone marrow B1 peripheral blood and C1 extramedullary disease status after 1 or 2 courses of induction chemotherapy proceed to consolidation therapy which begins upon recovery from induction therapy Consolidation therapy consists of PSC 833 over 2 hours on day 1 daunorubicin IV over 1-5 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 Treatment repeats for a total of 2 courses Patients are followed every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 20-55 patients will be accrued for this study within 8-9 months
OUTLINE This is a multicenter study Patients receive induction chemotherapy consisting of PSC 833 IV over 2 hours on day 1 then continuously for 96 hours daunorubicin IV continuously on days 1-3 and cytarabine IV continuously on days 1-7 Filgrastim G-CSF or sargramostim GM-CSF is administered subcutaneously SQ or IV beginning on day 15 and continuing until blood counts recover or day 21 If patients do not achieve complete remission after one course a second course is administered Patients who achieve A1 bone marrow B1 peripheral blood and C1 extramedullary disease status after 1 or 2 courses of induction chemotherapy proceed to consolidation therapy which begins upon recovery from induction therapy Consolidation therapy consists of PSC 833 over 2 hours on day 1 daunorubicin IV over 1-5 minutes on days 1 and 2 and cytarabine IV continuously on days 1-5 Treatment repeats for a total of 2 courses Patients are followed every 6 months for 2 years and then annually for 3 years
PROJECTED ACCRUAL A total of 20-55 patients will be accrued for this study within 8-9 months
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 |
|---|---|---|---|
| S9918 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |