Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003405
Status:
WITHDRAWN
Last Update Posted:
2021-10-14
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Biological Therapy in Treating Patients With Acute Myelogenous Leukemia
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
Treatment Protocol for Patients With Standard Risk Acute Myelogenous Leukemia and Its Variants Induction Using High-Dose Cytarabine Mitoxantrone and Ethyol Consolidation With Cytarabine and Idarubicin and Maintenance With 13 Cis Retinoic Acid and Alpha Interferon
Status:
WITHDRAWN
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No enrollment
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 Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing Combining more than one chemotherapy drug with biological therapy may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy isotretinoin and interferon alfa in treating patients who have acute myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy isotretinoin and interferon alfa in treating patients who have acute myelogenous leukemia
Detailed Description:
OBJECTIVES I Assess the efficacy of high dose cytarabine with mitoxantrone and amifostine as induction therapy for patients with previously untreated standard risk acute myelogenous leukemia AML II Assess the effects of amifostine on the biology of AML cells in vivo in these patients III Determine whether there is a relationship between cytokine production before and during remission induction therapy and treatment outcome
OUTLINE Prior to treatment patients undergo bone marrow aspirate and biopsy On day -3 patients receive idoxuridine IV over 60 minutes followed immediately by a bone marrow aspirate and biopsy Patients then receive amifostine IV over 5-7 minutes on the same day Prior to chemotherapy on day 1 patient receive broxuridine IV over 60 minutes immediately followed by bone marrow aspirate and biopsy Chemotherapy on day 1 consists of amifostine followed by cytarabine IV over 3 hours repeated every 12 hours and mitoxantrone IV over 1 hour immediately after the second infusion of cytarabine This course is repeated on day 5 after another bone marrow biopsy and aspirate Starting on day 6 patients receive amifostine 3 times a week until day 28 or beyond Patients who respond to treatment continue on to receive three courses of consolidation therapy Consolidation courses 1 and 3 consist of cytarabine continuous IV on days 1-7 and idarubicin IV over 30 minutes on days 1 2 and 3 Consolidation course 2 consists of cytarabine IV over 75 minutes repeated every 12 hours for 4 days Twenty-four hours after each course of consolidation therapy patients receive isotretinoin orally every day and interferon alfa subcutaneously every other day Isotretinoin and interferon alfa therapy are stopped 4 days prior to day 1 of the next course of consolidation therapy Following recovery from course 3 of consolidation therapy patients continue to receive isotretinoininterferon alfa until relapse Patients in complete remission after the 3 courses of consolidation therapy receive isotretinoininterferon alfa for 3 years Patients are followed every 3 months for the first year then every 6 months for the next 2 years
PROJECTED ACCRUAL There will be 40-45 patients accrued into this study
OUTLINE Prior to treatment patients undergo bone marrow aspirate and biopsy On day -3 patients receive idoxuridine IV over 60 minutes followed immediately by a bone marrow aspirate and biopsy Patients then receive amifostine IV over 5-7 minutes on the same day Prior to chemotherapy on day 1 patient receive broxuridine IV over 60 minutes immediately followed by bone marrow aspirate and biopsy Chemotherapy on day 1 consists of amifostine followed by cytarabine IV over 3 hours repeated every 12 hours and mitoxantrone IV over 1 hour immediately after the second infusion of cytarabine This course is repeated on day 5 after another bone marrow biopsy and aspirate Starting on day 6 patients receive amifostine 3 times a week until day 28 or beyond Patients who respond to treatment continue on to receive three courses of consolidation therapy Consolidation courses 1 and 3 consist of cytarabine continuous IV on days 1-7 and idarubicin IV over 30 minutes on days 1 2 and 3 Consolidation course 2 consists of cytarabine IV over 75 minutes repeated every 12 hours for 4 days Twenty-four hours after each course of consolidation therapy patients receive isotretinoin orally every day and interferon alfa subcutaneously every other day Isotretinoin and interferon alfa therapy are stopped 4 days prior to day 1 of the next course of consolidation therapy Following recovery from course 3 of consolidation therapy patients continue to receive isotretinoininterferon alfa until relapse Patients in complete remission after the 3 courses of consolidation therapy receive isotretinoininterferon alfa for 3 years Patients are followed every 3 months for the first year then every 6 months for the next 2 years
PROJECTED ACCRUAL There will be 40-45 patients accrued into this study
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 |
|---|---|---|---|
| NCI-V98-1445 | US NIH GrantContract | None | httpsreporternihgovquickSearchP01CA075606 |
| P01CA075606 | NIH | None | None |
| RUSH-AML-9754 | None | None | None |
| ALZA-RUSH-AML-9754 | None | None | None |