A Phase I, Single Dose Escalating Study to Investigate the Tolerability, Pharmacokinetics and Dosimetry of 90 Y-Humanized MN-14 IgG in Colorectal Cancer Patients With Limited Residual Disease After Primary or Salvage Surgery
Disease Characteristics:
- Patients with documented histologic and cytologic diagnosis of colon or rectal
malignancy
- Patients with documented status post surgical resection of primary cancer or
metastases
- Limited residual disease (i.e., CEA serum levels < 15 ng/mL and negative baseline CT
scans, or no lesion > 1 cm)
Prior/Concurrent Therapy:
- Patients must have completed chemotherapeutic agents, biologic therapy, radiotherapy,
other investigational therapy for cancer, or surgical procedures at least six weeks
prior to study entry.
- Patients must have recuperated from surgery and toxicities (as a result of previous
therapy) sufficiently prior to study entry
- Biologic Therapy: Patients who have received a murine, 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 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 organs (e.g., 3000 cGy for the liver; 2000 cGy for the lungs and kidneys)
Patient Characteristics/
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Lauri Welles, MD
Study Chair
Immunomedics, Inc.
United States: Food and Drug Administration
IM-T-hMN14-06
NCT00041691
Name | Location |
---|---|
Virginia Mason Medical Center | Seattle, Washington 98111 |
Washington Hospital Center | Washington, District of Columbia 20010 |