Combined Modality Radioimmunotherapy For Metastatic Breast Adenocarcinoma With Two Cycles Of Escalating Dose 90Y-DOTA-Peptide-m170 and Fixed, Low Dose Paclitaxel With Blood Stem Cell Support And Cyclosporin For HAMA Suppression
- Determine the maximum tolerated dose of yttrium Y 90 monoclonal antibody m170 in
combination with cyclosporine and paclitaxel in patients with recurrent or refractory
metastatic breast cancer.
- Determine the preliminary efficacy of this regimen in these patients.
OUTLINE: This is a dose-escalation study of yttrium Y 90 monoclonal antibody m170 (Y90 MOAB
Patients receive filgrastim (G-CSF) subcutaneously (SC) daily for 4 days prior to apheresis
which continues daily for a maximum of 5 days. A minimum of 6 million CD34+ cells/kg must be
Patients receive oral cyclosporine every 12 hours on days -3 to 25. Patients receive
unlabeled monoclonal antibody (MOAB) m170 IV followed by a tracer dose of indium In 111 MOAB
m170 IV on day 0. On day 7, patients receive unlabeled MOAB m170 IV followed by Y90 MOAB
m170 IV. Patients in cohorts 2-4 also receive paclitaxel IV over 3 hours on day 9.
If needed, patients undergo autologous peripheral blood stem cell transplantation on day 21
and receive G-CSF SC daily until blood counts recover.
Cohorts of 3-6 patients receive escalating doses of Y90 MOAB m170 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for 3 months, every 3 months for 1 year, and then every 6
months for 1 year.
PROJECTED ACCRUAL: A total of 18-30 patients will be accrued for this study within 36
Primary Purpose: Treatment
Carol M. Richman, MD
University of California, Davis
United States: Federal Government
|University of California Davis Cancer Center||Sacramento, California 95817|