Radioimmunotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Stage IV Breast Cancer
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by radioimmunotherapy used to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody therapy plus peripheral stem cell transplantation in treating patients who have stage IV breast cancer.
|Breast Cancer||Biological: filgrastim Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: yttrium Y 90 monoclonal antibody MN-14||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Safety [ Time Frame: 12 weeks ]maximum tolerated dose
|Study Start Date:||May 1998|
|Primary Completion Date:||May 2002 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004085
|United States, New Jersey|
|Garden State Cancer Center|
|Belleville, New Jersey, United States, 07103|
|St. Joseph's Hospital and Medical Center|
|Paterson, New Jersey, United States, 07503|
|United States, Pennsylvania|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Jack D. Burton, MD||Garden State Cancer Center at the Center for Molecular Medicine and Immunology|