Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006040
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-07-05
Brief Title:
Radiolabeled Monoclonal Antibody Therapy and Etoposide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Myelodysplastic Syndrome or Refractory Leukemia
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase I Study of Yttrium-90 Labeled HuM195 Combined With Etoposide as a Conditioning Regimen for Autologous Stem Cell Transplantation in Patients With Advanced Myelodysplastic Syndrome and Refractory Leukemia
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 Radiolabeled monoclonal antibodies can locate cancer cells and deliver radiation to them without harming normal cells Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Peripheral stem cell transplantation may allow the doctor to give higher doses of radiation and chemotherapy drugs and kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy plus etoposide followed by peripheral stem cell transplantation in treating patients who have advanced myelodysplastic syndrome or refractory leukemia
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy plus etoposide followed by peripheral stem cell transplantation in treating patients who have advanced myelodysplastic syndrome or refractory leukemia
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of yttrium Y 90 humanized monoclonal antibody M195 when combined with etoposide as a preparative regimen for autologous peripheral blood stem cell transplantation in patients with advanced myelodysplastic syndrome or refractory leukemia
Determine the qualitative toxicities associated with this regimen in this patient population
Assess preliminary information on engraftment following this conditioning regimen in these patients
OUTLINE This is a dose escalation study of yttrium Y 90 humanized monoclonal antibody M195 Y90 MOAB M195
Patients receive Y90 MOAB M195 IV over 40 minutes once between days -12 to -9 and etoposide IV over several hours on day -3 Peripheral blood stem cells or bone marrow are reinfused on day 0 Patients receive filgrastim G-CSF subcutaneously beginning on day 1 until hematopoietic recovery
Cohorts of 3-6 patients receive escalating doses of Y90 MOAB M195 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicities
Patients are followed between days 10 and 14 and then monthly for 6 months
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for this study within 12 months
Determine the maximum tolerated dose of yttrium Y 90 humanized monoclonal antibody M195 when combined with etoposide as a preparative regimen for autologous peripheral blood stem cell transplantation in patients with advanced myelodysplastic syndrome or refractory leukemia
Determine the qualitative toxicities associated with this regimen in this patient population
Assess preliminary information on engraftment following this conditioning regimen in these patients
OUTLINE This is a dose escalation study of yttrium Y 90 humanized monoclonal antibody M195 Y90 MOAB M195
Patients receive Y90 MOAB M195 IV over 40 minutes once between days -12 to -9 and etoposide IV over several hours on day -3 Peripheral blood stem cells or bone marrow are reinfused on day 0 Patients receive filgrastim G-CSF subcutaneously beginning on day 1 until hematopoietic recovery
Cohorts of 3-6 patients receive escalating doses of Y90 MOAB M195 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicities
Patients are followed between days 10 and 14 and then monthly for 6 months
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for this study within 12 months
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-G00-1815 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068055 | REGISTRY | None | None |