Leukemia Clinical Trial
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
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.
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.
;
Primary Purpose: Treatment
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