Breast Cancer Clinical Trial
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
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.
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.
;
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