Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002890
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy in Treating Patients With Myelodysplastic Syndrome or Relapsed or Refractory Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
PHASE I DOSE-ESCALATION TRIAL OF YTTRIUM-90-LABELED HuM195 HUMANIZED ANTI-CD33 IN PATIENTS WITH ADVANCED MYELOID MALIGNANCIES
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 Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients with myelodysplastic syndrome or relapsed or refractory acute myeloid leukemia or chronic myelogenous leukemia
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients with myelodysplastic syndrome or relapsed or refractory acute myeloid leukemia or chronic myelogenous leukemia
Detailed Description:
OBJECTIVES I Determine the safety and toxicity of yttrium-90-labeled humanized monoclonal antibody M195 90Y-MOAB HuM195 in patients with relapsed or refractory myeloid malignancies II Determine the pharmacology and dosimetry of 90Y-MOAB HuM195 III Study the biological effects of 90Y-MOAB HuM195 including the ability to elicit human anti-human antibody responses and antileukemic responses
OUTLINE This study seeks to estimate the maximum tolerated dose MTD of yttrium-90-labeled humanized monoclonal antibody M195 90Y-MOAB HuM195 All patients receive a single intravenous dose of 90Y-MOAB HuM195 Groups of 3 to 6 patients are treated at escalated doses of yttrium-90 until the MTD is determined Patients with active leukemia who exhibit at least a 50 clearing of marrow blasts after the first dose may receive a second dose after 4-8 weeks provided remaining blasts are CD33-positive there is no evidence of human anti-human antibody response and any toxicity has resolved All patients are followed monthly for 4 months after treatment
PROJECTED ACCRUAL Up to 24 patients will be treated The study is expected to require 12-18 months to complete
OUTLINE This study seeks to estimate the maximum tolerated dose MTD of yttrium-90-labeled humanized monoclonal antibody M195 90Y-MOAB HuM195 All patients receive a single intravenous dose of 90Y-MOAB HuM195 Groups of 3 to 6 patients are treated at escalated doses of yttrium-90 until the MTD is determined Patients with active leukemia who exhibit at least a 50 clearing of marrow blasts after the first dose may receive a second dose after 4-8 weeks provided remaining blasts are CD33-positive there is no evidence of human anti-human antibody response and any toxicity has resolved All patients are followed monthly for 4 months after treatment
PROJECTED ACCRUAL Up to 24 patients will be treated The study is expected to require 12-18 months to complete
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-H96-1100 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065213 | REGISTRY | None | None |