Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014495
Status:
COMPLETED
Last Update Posted:
2016-01-22
First Post:
2001-04-10
Brief Title:
Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase III Trial Of Sequential Therapy With Cytarabine And Bismuth-213-Labeled HuM195 Humanized Anti-CD33 In Patients With Advanced Myeloid Malignancies
Status:
COMPLETED
Status Verified Date:
2015-12
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 monoclonal antibody therapy with chemotherapy may kill more cancer cells
PURPOSE Phase III trial to study the effectiveness of combining chemotherapy and monoclonal antibody therapy in treating patients who have advanced myeloid cancer
PURPOSE Phase III trial to study the effectiveness of combining chemotherapy and monoclonal antibody therapy in treating patients who have advanced myeloid cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of bismuth Bi 213 monoclonal antibody M195 following cytarabine in patients with advanced myeloid malignancies
Determine the antileukemic effects of this treatment in this patient population
Determine the toxicity of this treatment in this patient population
Determine the complete remission rate of patients treated with this treatment regimen
OUTLINE This is a dose escalation study of bismuth Bi 213 monoclonal antibody M195 Bi213 MOAB M195
Patients receive cytarabine IV continuously on days 1-5 Beginning between days 7 and 14 patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days Patient also receive filgrastim G-CSF subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined subsequent patients are treated at the MTD
Patients are followed twice weekly for 4 weeks and then monthly for 3 months
Determine the maximum tolerated dose of bismuth Bi 213 monoclonal antibody M195 following cytarabine in patients with advanced myeloid malignancies
Determine the antileukemic effects of this treatment in this patient population
Determine the toxicity of this treatment in this patient population
Determine the complete remission rate of patients treated with this treatment regimen
OUTLINE This is a dose escalation study of bismuth Bi 213 monoclonal antibody M195 Bi213 MOAB M195
Patients receive cytarabine IV continuously on days 1-5 Beginning between days 7 and 14 patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days Patient also receive filgrastim G-CSF subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined subsequent patients are treated at the MTD
Patients are followed twice weekly for 4 weeks and then monthly for 3 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 |
|---|---|---|---|
| NCI-H01-0071 | None | None | None |
| MSKCC-00117 | None | None | None |