Phase I/II Trial of High-Dose Radioimmunotherapy With a 90Y-Humanized MN-14 Anti-Carcinoembryonic Antigen (CEA) Antibody for the Treatment of Stage IV Breast Cancer
OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of yttrium Y
90 monoclonal antibody MN-14 (Y90 MOAB MN-14) plus peripheral blood stem cell rescue in
patients with stage IV breast cancer. II. Determine the pharmacokinetic profile of Y90 MOAB
MN-14 in the blood, normal organs, and tumors of this patient population. III. Determine the
antibody response to Y90 MOAB MN-14 in these patients. IV. Determine the antitumor effect of
this regimen in these patients. V. Determine the radiation absorbed dose to normal organs
and tumors.
OUTLINE: This is a dose-escalation, multicenter study. Patients receive filgrastim (G-CSF)
subcutaneously (SC) with or without chemotherapy on days -28 to -14 and peripheral blood
stem cell (PBSC) collection on days -14 to -11. If an adequate number of CD34+ cells are not
harvested, bone marrow may be collected. Patients receive pretherapy imaging with indium In
111 monoclonal antibody MN-14 IV for up to 40 minutes on day -7 followed by whole body
imaging on days -7 to 0. Patients receive yttrium Y 90 monoclonal antibody MN-14 (Y90 MOAB
MN-14) IV for up to 40 minutes on day 0. PBSC or bone marrow is reinfused on days 6 to 14,
depending on antibody clearance. Patients receive G-CSF SC or IV until blood counts recover.
Cohorts of 3-6 patients receive escalating doses of Y90 MOAB MN-14 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose-limiting toxicity. Patients are followed weekly for 2 months,
monthly for 6 months, and then every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 24-30 patients will be accrued for this study within 2.5
years.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety
maximum tolerated dose
12 weeks
No
Jack D. Burton, MD
Study Chair
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
United States: Food and Drug Administration
CDR0000067297
NCT00004085
May 1998
Name | Location |
---|---|
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
St. Joseph's Hospital and Medical Center | Paterson, New Jersey 07503 |
Garden State Cancer Center | Belleville, New Jersey 07103 |