A Phase I/II Study of Radioimmunotherapy With 90Y-Humanized MN-14 IgG Administered as a Single Dose to Patients With Refractory Metastatic/Recurrent Colorectal Carcinomas
- Patients with a documented histologic or cytologic diagnosis of a colonic or rectal
- 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 measurable tumor site* with no
tumor site > 5 cm in the greatest dimension.
- 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. Patients must have completed
chemotherapeutic agents four weeks prior to study entry.
- 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 hMN-14 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, and 2,000 cGy for the lungs and kidneys). Patients who have had
standard pelvic field radiation as adjuvant therapy for rectal carcinoma will be
eligible only after the MTD is established.
- Other: Any experimental therapy (i.e., drugs, biologicals, 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|