A Phase I/II Study of Radioimmunotherapy With 90Y-Humanized MN-14 IgG Administered as a Single Dose to Patients With Refractory Advanced/Metastatic Pancreatic Carcinoma
- Patients with a documented histologic or cytologic diagnosis of a pancreatic
- Patients with recurrent, advanced and/or metastatic disease, who have either failed
standard therapy or are not eligible for any alternate therapies of higher
- Patients with at least one identified (confirmed) and measureable tumor site.
- Surgery: Patients are excluded if they have had major surgery either during or within
four weeks prior to study entry.
- Chemotherapy: Patients must have failed standard therapy or are not eligible for any
alternate therapies of higher therapeutic priority.
- Biologic Therapy: Patients who have received a chimeric, CDR-grafted (humanized), or
human IgG will be eligible provided pre-study evaluations demonstrate no significant
reactivity with hMN14 IgG (i.e., HAHA)
- Radiotherapy: No prior radiotherapy within four weeks of study entry. No prior
external beam irradiation to a field that includes more than 30% of the red marrow.
No prior radiation to maximal tolerable levels for any critical organ (e.g., 3,000
cGy for the liver; 2,000 cGy for the lungs and kidneys).
- Other: Any experimental therapy (i.e., drugs, biologics, procedures) for the primary
malignancy, either during or within four weeks prior to study entry.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
William Wegener, MD
United States: Food and Drug Administration
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|Virginia Mason Medical Center||Seattle, Washington 98111|
|Washington Hospital Center||Washington, District of Columbia 20010|
|Hoag Cancer Center||Newport Beach, California 92658|
|Bay Pines VA Medical Center||St. Petersburg, Florida 33744|