Monoclonal Antibody Therapy Plus Cyclosporine and Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT00003920|
Recruitment Status : Unknown
Verified November 2000 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : June 17, 2004
Last Update Posted : August 7, 2013
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 body's 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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: filgrastim Drug: cyclosporine Procedure: peripheral blood stem cell transplantation Radiation: indium In 111 monoclonal antibody m170 Radiation: yttrium Y 90 monoclonal antibody m170||Phase 1|
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 111In/90Y-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 111/Y 90 labeled 2IT-BAD monoclonal antibody 170 (111In/90Y-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 111In/90Y-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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Official Title:||Pharmacokinetic/Dosimetry/MTNTD Study of 111In/90Y-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|
|Study Start Date :||April 1996|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003920
|United States, California|
|University of California Davis Medical Center|
|Sacramento, California, United States, 95817|
|Study Chair:||Sally DeNardo, MD||University of California, Davis|