Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003920
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
1999-11-01
Brief Title:
Monoclonal Antibody Therapy Plus Cyclosporine and Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Breast Cancer
Sponsor:
University of California Davis
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PharmacokineticDosimetryMTNTD Study of 111In90Y-2IT-BAD-m170 for Therapy in Metastatic Breast Cancer Patients With Post Therapy Support of Autologous Pretherapy Apheresed Peripheral Blood Stem Cells and Cyclosporin A Given for Suppression of HAMA Response
Status:
UNKNOWN
Status Verified Date:
2000-11
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 Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells Sometimes the transplanted cells can make an immune response against the bodys normal tissues Cyclosporine may prevent this from happening
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody plus cyclosporine and peripheral stem cell transplantation in treating patients who have metastatic breast cancer that has not responded to previous therapy
PURPOSE Phase I trial to study the effectiveness of radiolabeled monoclonal antibody plus cyclosporine and peripheral stem cell transplantation in treating patients who have metastatic breast cancer that has not responded to previous therapy
Detailed Description:
OBJECTIVES I Determine variation in indium In 111 labeled 2IT-BAD monoclonal antibody 170 111In-2IT-BAD-m170 pharmacokinetics before and with each therapy in patients with metastatic breast cancer II Determine each therapeutic dose of yttrium Y 90 labeled 2IT-BAD monoclonal antibody 170 90Y-2IT-BAD-m170 based on the calculated radiation dosimetry for normal nonmarrow tissues from the pharmacokinetic study with 111In-2IT-BAD-m170 performed prior to each therapy course in these patients III Determine the maximum tolerated nonmarrow normal tissue dose MTNTD of 90Y-2IT-BAD-m170 for these patients when up to 3 courses with cyclosporine plus autologous peripheral stem cell support are given every 3 months IV Evaluate the safety of and tumor response to 111In90Y-2IT-BAD-m170 therapy with cyclosporine and autologous peripheral stem cells at the MTNTD in these patients
OUTLINE This is a dose escalation study of yttrium Y 90 labeled 2IT-BAD monoclonal antibody 170 90Y-2IT-BAD-m170 Patients are stratified according to risk based on prior therapy standard combined chemotherapy vs standard and high dose combined chemotherapy with bone marrow transplant or stem cell support All patients receive subcutaneous filgrastim G-CSF during stem cell collection Beginning 3 to 5 days after starting G-CSF patients undergo apheresis either daily or every other day for 4 to 8 procedures Patients receive oral cyclosporine twice daily starting on day 1 for up to 2 weeks On day 4 patients receive nonlabeled 2IT-BAD monoclonal antibody m170 IV over 10-15 minutes followed 15 minutes later by indium In 111 labeled 2IT-BAD monoclonal antibody 170 111In-2IT-BAD-m170 IV over 10-15 minutes Patients then undergo dosimetry imaging immediately again 3 hours later and then on days 1-4 and day 7 postinjection Patients receive nonlabeled monoclonal antibody IV over 10-15 minutes followed 15 minutes later by In 111Y 90 labeled 2IT-BAD monoclonal antibody 170 111In90Y-2IT-BAD-m170 IV over 10-15 minutes then undergo imaging as in pretherapy Patients also receive cyclosporine administered as in pretherapy for a total of 35 days plus autologous stem cell support followed by G-CSF after each course Cohorts of 3-9 patients receive escalating doses of 111In90Y-2IT-BAD-m170 Patients proceed to the next dose level if 3 or more patients in the same or higher risk group have not reached the maximum tolerated nonmarrow normal tissue dose MTNTD at least 3 months after the second course of therapy Therapy repeats every 3 months for 3 courses
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study
OUTLINE This is a dose escalation study of yttrium Y 90 labeled 2IT-BAD monoclonal antibody 170 90Y-2IT-BAD-m170 Patients are stratified according to risk based on prior therapy standard combined chemotherapy vs standard and high dose combined chemotherapy with bone marrow transplant or stem cell support All patients receive subcutaneous filgrastim G-CSF during stem cell collection Beginning 3 to 5 days after starting G-CSF patients undergo apheresis either daily or every other day for 4 to 8 procedures Patients receive oral cyclosporine twice daily starting on day 1 for up to 2 weeks On day 4 patients receive nonlabeled 2IT-BAD monoclonal antibody m170 IV over 10-15 minutes followed 15 minutes later by indium In 111 labeled 2IT-BAD monoclonal antibody 170 111In-2IT-BAD-m170 IV over 10-15 minutes Patients then undergo dosimetry imaging immediately again 3 hours later and then on days 1-4 and day 7 postinjection Patients receive nonlabeled monoclonal antibody IV over 10-15 minutes followed 15 minutes later by In 111Y 90 labeled 2IT-BAD monoclonal antibody 170 111In90Y-2IT-BAD-m170 IV over 10-15 minutes then undergo imaging as in pretherapy Patients also receive cyclosporine administered as in pretherapy for a total of 35 days plus autologous stem cell support followed by G-CSF after each course Cohorts of 3-9 patients receive escalating doses of 111In90Y-2IT-BAD-m170 Patients proceed to the next dose level if 3 or more patients in the same or higher risk group have not reached the maximum tolerated nonmarrow normal tissue dose MTNTD at least 3 months after the second course of therapy Therapy repeats every 3 months for 3 courses
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V99-1549 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067105 | REGISTRY | None | None |