Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer
Recruitment status was: Active, not recruiting
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with cyclosporine and paclitaxel may be an effective treatment for metastatic breast cancer.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy, cyclosporine, and paclitaxel in treating patients who have recurrent or refractory metastatic breast cancer.
|Breast Cancer||Biological: filgrastim Biological: monoclonal antibody m170 Drug: cyclosporine Drug: paclitaxel Procedure: peripheral blood stem cell transplantation Radiation: yttrium Y 90 monoclonal antibody m170||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||March 2001|
- 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 m170).
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 harvested.
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 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00009763
|United States, California|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|Study Chair:||Carol M. Richman, MD||University of California, Davis|