Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009763
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2001-02-02
Brief Title:
Monoclonal Antibody Therapy Cyclosporine and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer
Sponsor:
University of California Davis
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2003-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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 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
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
Detailed Description:
OBJECTIVES
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 cellskg 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
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 cellskg 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
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-V00-1640 | None | None | None |
| UCD-992080 | None | None | None |