Phase I/II Radioimmunotherapy With High-Dose 90Y-Labeled Humanized MN-14 in Advanced Metastatic Colorectal Cancer and Pancreatic Cancers Using Autologous Peripheral Blood Stem Cell Rescue (PBSCR) to Control Myelotoxicity
OBJECTIVES: I. Determine the maximum tolerated dose and secondary organ toxicity of high
dose yttrium Y 90 monoclonal antibody MN-14 (90Y-hMN-14) plus autologous peripheral blood
stem cell rescue in patients with metastatic or recurrent colorectal or pancreatic cancer.
II. Compare the tumor to organ dose ratio between 90Y-hMN-14 and iodine 131 monoclonal
antibody MN-14 (131I-MN-14) in these patients. III. Determine the antitumor effects with
myeloablative doses of 90Y-hMN-14. IV. Evaluate the immunogenicity of 90Y-hMN-14 in these
patients.
OUTLINE: This is a dose escalation of yttrium Y 90 monoclonal antibody MN-14 (90Y-hMN-14),
multicenter study. Patients are stratified by prior radiotherapy (yes vs no). Patients
receive filgrastim (G-CSF) subcutaneously on days -18 to -14 and peripheral blood stem cell
(PBSC) collection on days -15 to -13. If an adequate number of CD34+ cells are not
harvested, bone marrow is also collected. Patients receive pretherapy imaging with indium In
111 monoclonal antibody MN-14 (IN111-MN-14) IV on days -7 to 0. Patients receive 90Y-hMN-14
for up to 40 minutes on day 0. PBSC are reinfused on days 7 to 14. Patients receive G-CSF SQ
until blood counts recover. Cohorts of 3-6 patients receive escalating doses of 90Y-hMN-14
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at
which 2 of 3 or 2 of 6 patients experience dose limiting toxicity. Patients are followed at
1-4, 6, 8, 12, and 24 weeks, and then every 6 months thereafter for up to 5 years.
PROJECTED ACCRUAL: A total of 24-30 patients will be accrued for this study within 2 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
CDR0000067300
NCT00004087
March 1997
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 |