Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002805
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Acute Myeloid Leukemia Salvage Therapy for Patients in First Relapse or Who Fail to Achieve an Initial Remission or Who Develop AML as a Second Malignant Neoplasm
Status:
COMPLETED
Status Verified Date:
2014-07
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
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome in first relapse or who did not achieve first remission
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome in first relapse or who did not achieve first remission
Detailed Description:
OBJECTIVES I Determine the toxicity remission rate event-free survival and overall survival following induction with cytarabinemitoxantrone ARA-CDHAD intensification with ARA-C and etoposide VP-16 and consolidation with cladribine 2-CdA and VP-16 in patients with acute myeloid leukemia AML that is secondary in first relapse or has failed initial remission induction therapy II Compare the remission induction rate and event-free survival on this trial with prior second-line studies ie protocols CCG-243 CCG-201 and CCG-261P III Compare survival of patients on this trial with the survival of patients relapsing or failing to achieve an initial complete remission CR on previous front-line AML trials ie protocols CCG-251 CCG-213 CCG-2861 and CCG-2891 IV Determine the frequency and prognostic significance of mdr1 gene expression and p53 topoisomerase II and deoxycytidine kinase gene mutations in these patients V Determine the disease-free and overall survival of patients achieving a CR on this study in relation to the post-intensification therapy received ie bone marrow transplantation chemotherapy or no further therapy VI Determine the frequency and degree of abnormal cardiac function on echocardiogram or MUGA at 1 and 5 years in patients treated with mitoxantrone following anthracycline therapy during initial treatment VII Provide a control arm evaluating the safety of using phase I or II agents in an upfront window approach planned for future CCG studies VIII Determine the toxicity remission rate event-free survival and overall survival in patients who fail to achieve a CR with ARA-CDHAD induction and are then treated with 2-CdAVP-16 IX Determine the biologic characteristics toxicity remission rate event-free survival and overall survival following this treatment regimen in patients who develop AML as a second malignancy
OUTLINE Patients who do not achieve M1M2a marrow following Induction proceed to Salvage Induction all others proceed to Intensification Patients receive Consolidation therapy on Regimen A B or C according to the investigators choice The following acronyms are used ARA-C Cytarabine NSC-63878 2-CdA Cladribine 2-Chlorodeoxyadenosine NSC-105014 DHAD Mitoxantrone NSC-301739 G-CSF Filgrastim NSC-614629 HC Hydrocortisone NSC-10483 HD High Dose MTX Methotrexate NSC-740 PBSC Peripheral Blood Stem Cells TBI Total-Body Irradiation TIT Triple Intrathecal Therapy IT ARA-CIT HCIT MTX VP-16 Etoposide NSC-141540 INDUCTION 2-Drug Combination Chemotherapy plus CNS ProphylaxisTherapy ARA-CDHAD G-CSF plus IT ARA-C and if CNS disease at entry TIT SALVAGE INDUCTION 2-Drug Combination Chemotherapy 2-CdAVP-16 INTENSIFICATION 2-Drug Combination Chemotherapy followed as indicated by Radiotherapy HD ARA-CVP-16 followed in patients with persistent CNS disease CNS relapse or chloromas by irradiation using megavoltage equipment minimum Co60 and maximum 6 MV x-rays or electrons CONSOLIDATION Regimen A 2-Drug Combination Chemotherapy 2-CdAVP-16 Regimen B Myeloablative Chemoradiotherapy followed by Hematopoietic Rescue TBI equipment unspecified with electron boosts to the testes chest extramedullary sites and if indicated craniospinal region VP-16 followed by allogeneic or autologous bone marrow or PBSC Regimen C No further therapy
PROJECTED ACCRUAL A total of 90 patients will be entered The study may be closed if there are 7 or more deaths in the first 45 patients who complete Intensification
OUTLINE Patients who do not achieve M1M2a marrow following Induction proceed to Salvage Induction all others proceed to Intensification Patients receive Consolidation therapy on Regimen A B or C according to the investigators choice The following acronyms are used ARA-C Cytarabine NSC-63878 2-CdA Cladribine 2-Chlorodeoxyadenosine NSC-105014 DHAD Mitoxantrone NSC-301739 G-CSF Filgrastim NSC-614629 HC Hydrocortisone NSC-10483 HD High Dose MTX Methotrexate NSC-740 PBSC Peripheral Blood Stem Cells TBI Total-Body Irradiation TIT Triple Intrathecal Therapy IT ARA-CIT HCIT MTX VP-16 Etoposide NSC-141540 INDUCTION 2-Drug Combination Chemotherapy plus CNS ProphylaxisTherapy ARA-CDHAD G-CSF plus IT ARA-C and if CNS disease at entry TIT SALVAGE INDUCTION 2-Drug Combination Chemotherapy 2-CdAVP-16 INTENSIFICATION 2-Drug Combination Chemotherapy followed as indicated by Radiotherapy HD ARA-CVP-16 followed in patients with persistent CNS disease CNS relapse or chloromas by irradiation using megavoltage equipment minimum Co60 and maximum 6 MV x-rays or electrons CONSOLIDATION Regimen A 2-Drug Combination Chemotherapy 2-CdAVP-16 Regimen B Myeloablative Chemoradiotherapy followed by Hematopoietic Rescue TBI equipment unspecified with electron boosts to the testes chest extramedullary sites and if indicated craniospinal region VP-16 followed by allogeneic or autologous bone marrow or PBSC Regimen C No further therapy
PROJECTED ACCRUAL A total of 90 patients will be entered The study may be closed if there are 7 or more deaths in the first 45 patients who complete Intensification
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 |
|---|---|---|---|
| CDR0000064907 | OTHER | Clinical Trialsgov | None |
| CCG-2951 | None | None | None |