Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002598
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Interferon Alfa in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A PHASE II STUDY OF MITOXANTRONE AND HIGH-DOSE ARA-C FOLLOWED BY INTENSIVE CONSOLIDATION WITH CYCLOPHOSPHAMIDE AND ETOPOSIDE FOR MYELOID BLAST CRISIS OF CHRONIC MYELOGENOUS LEUKEMIA CML
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells Interferon alfa may interfere with the growth of cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and interferon alfa in treating patients with chronic myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and interferon alfa in treating patients with chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Determine the effectiveness of induction with high-dose mitoxantrone and cytarabine in patients with chronic myelogenous leukemia CML in blast crisis
Determine the toxicity and activity of consolidation with high-dose cyclophosphamide and etoposide in these patients
Determine the toxicity and activity of maintenance with interferon alfa in these patients
Determine the efficacy and tolerability of this regimen in these patients
Assess minimal residual disease by cytogenetics DNA gene rearrangement Southern blotting and polymerase chain reaction PCR in patients treated with this regimen and use semiquantitative PCR to evaluate the antileukemic activity of subsequent phases of treatment in patients achieving complete remission
OUTLINE Patients are stratified by prior therapy for blast crisis yes vs no
Induction Patients receive high-dose cytarabine IV over 3 hours on days 1-5 and mitoxantrone IV on day 3 Sargramostim GM-CSF is administered subcutaneously SC or IV over 4 hours daily beginning on day 7 and continuing until blood counts recover After completion of induction patients with a suitable HLA-identical bone marrow donor undergo allogeneic bone marrow transplantation according to an appropriate IRB-approved protocol Patients without a donor proceed to consolidation approximately 4 weeks after hospital discharge following induction
Consolidation Patients receive high-dose cyclophosphamide IV on days 1-4 and etoposide IV continuously on days 5-7 GM-CSF is administered SC or IV over 4 hours beginning on day 8 and continuing until blood counts recover Patients achieving a second chronic phase or complete remission proceed to maintenance approximately 4 weeks after hospital discharge following consolidation
Maintenance Patients receive interferon alfa SC on day 1 Treatment with interferon alfa continues daily in the absence of disease progression or unacceptable toxicity
Patients with CNS involvement at entry or who develop CNS disease during the study receive CNS therapy as outlined below
CNS therapy Patients undergo whole brain irradiation as soon as possible but not concurrently with mitoxantrone Patients also receive methotrexate intrathecally 3 times a week until the CSF is clear weekly for 4 weeks and then monthly for 6 months
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study within 4 years
Determine the effectiveness of induction with high-dose mitoxantrone and cytarabine in patients with chronic myelogenous leukemia CML in blast crisis
Determine the toxicity and activity of consolidation with high-dose cyclophosphamide and etoposide in these patients
Determine the toxicity and activity of maintenance with interferon alfa in these patients
Determine the efficacy and tolerability of this regimen in these patients
Assess minimal residual disease by cytogenetics DNA gene rearrangement Southern blotting and polymerase chain reaction PCR in patients treated with this regimen and use semiquantitative PCR to evaluate the antileukemic activity of subsequent phases of treatment in patients achieving complete remission
OUTLINE Patients are stratified by prior therapy for blast crisis yes vs no
Induction Patients receive high-dose cytarabine IV over 3 hours on days 1-5 and mitoxantrone IV on day 3 Sargramostim GM-CSF is administered subcutaneously SC or IV over 4 hours daily beginning on day 7 and continuing until blood counts recover After completion of induction patients with a suitable HLA-identical bone marrow donor undergo allogeneic bone marrow transplantation according to an appropriate IRB-approved protocol Patients without a donor proceed to consolidation approximately 4 weeks after hospital discharge following induction
Consolidation Patients receive high-dose cyclophosphamide IV on days 1-4 and etoposide IV continuously on days 5-7 GM-CSF is administered SC or IV over 4 hours beginning on day 8 and continuing until blood counts recover Patients achieving a second chronic phase or complete remission proceed to maintenance approximately 4 weeks after hospital discharge following consolidation
Maintenance Patients receive interferon alfa SC on day 1 Treatment with interferon alfa continues daily in the absence of disease progression or unacceptable toxicity
Patients with CNS involvement at entry or who develop CNS disease during the study receive CNS therapy as outlined below
CNS therapy Patients undergo whole brain irradiation as soon as possible but not concurrently with mitoxantrone Patients also receive methotrexate intrathecally 3 times a week until the CSF is clear weekly for 4 weeks and then monthly for 6 months
PROJECTED ACCRUAL A total of 14-30 patients will be accrued for this study within 4 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-V94-0541 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000063832 | REGISTRY | None | None |