Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028899
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
2002-01-04
Brief Title:
Monoclonal Antibody Plus Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Dose Finding Study of the Safety of Gemtuzumab Ozogamicin Combined With Conventional Chemotherapy for Patients With Relapsed or Refractory Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells Combining monoclonal antibody therapy with combination chemotherapy may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of combining gemtuzumab ozogamicin with combination chemotherapy in treating children who have relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome
PURPOSE Phase I trial to study the effectiveness of combining gemtuzumab ozogamicin with combination chemotherapy in treating children who have relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Determine the safety and maximum tolerated dose of gemtuzumab ozogamicin in combination with conventional chemotherapy in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndromes
Determine the efficacy of this regimen in these patients
Correlate the likelihood of leukemic blast cells to undergo apoptosis in vitro with the efficacy of this regimen in these patients
Correlate drug resistance as manifested by dye efflux or multiple drug resistance-1 expression by leukemic blast cells with the efficacy of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study of gemtuzumab ozogamicin Patients are assigned by cohort to 1 of 2 treatment regimens
Regimen A Patients receive cytarabine IV over 2 hours every 12 hours on days 1-4 mitoxantrone IV over 1 hour on days 3-6 and gemtuzumab ozogamicin IV over 2 hours on day 7
Regimen B Patients receive cytarabine IV over 3 hours every 12 hours on days 1 2 8 and 9 asparaginase intramuscularly on days 2 and 9 and gemtuzumab ozogamicin IV over 2 hours on day 3
Cohorts of 3-6 patients receive de-escalating doses of gemtuzumab ozogamicin until the maximum tolerated dose MTD is determined The MTD is defined as the dose below that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed monthly for 6 months every 2 months for 6 months every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 52 patients will be accrued for this study within 15 years
Determine the safety and maximum tolerated dose of gemtuzumab ozogamicin in combination with conventional chemotherapy in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndromes
Determine the efficacy of this regimen in these patients
Correlate the likelihood of leukemic blast cells to undergo apoptosis in vitro with the efficacy of this regimen in these patients
Correlate drug resistance as manifested by dye efflux or multiple drug resistance-1 expression by leukemic blast cells with the efficacy of this regimen in these patients
OUTLINE This is a dose-escalation multicenter study of gemtuzumab ozogamicin Patients are assigned by cohort to 1 of 2 treatment regimens
Regimen A Patients receive cytarabine IV over 2 hours every 12 hours on days 1-4 mitoxantrone IV over 1 hour on days 3-6 and gemtuzumab ozogamicin IV over 2 hours on day 7
Regimen B Patients receive cytarabine IV over 3 hours every 12 hours on days 1 2 8 and 9 asparaginase intramuscularly on days 2 and 9 and gemtuzumab ozogamicin IV over 2 hours on day 3
Cohorts of 3-6 patients receive de-escalating doses of gemtuzumab ozogamicin until the maximum tolerated dose MTD is determined The MTD is defined as the dose below that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed monthly for 6 months every 2 months for 6 months every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 52 patients will be accrued for this study within 15 years
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 |
|---|---|---|---|
| COG-AAML00P2 | OTHER | None | None |
| CDR0000069145 | OTHER | ClinicalTrialsgov | None |