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
- 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
- Determine the qualitative toxicities associated with this regimen in this patient
- Assess preliminary information on engraftment following this conditioning regimen in
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
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.
Primary Purpose: Treatment
Peter Maslak, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|