The purpose of this trial is to determine the safety of hMN14 at different dose levels in
the treatment of either colorectal or breast cancer.
- Histologic or cytologic diagnosis or either, colonic, rectal, or breast carcinoma
- Measurable lesion diagnosed by CT scan
- Recurrent/metastatic disease considered surgically unresectable.
- Chemotherapy: Patients who either have failed at least one regimen of standard
systemic therapy, or are clinically asymptomatic and are not presently being
considered for chemotherapy (Enrollment must occur at least 4 weeks beyond last
- Other: Prior treatment with investigational agents is excluded unless follow-up is
completed and patient is off study
Patient Characteristics/Inclusion Criteria:
- Performance Status: Patients with a Karnofsky performance status > 70% (or
equivalent, ECOG 0-1) and expected survival of at least 3 months.
- Hematopoietic: WBC >/= 3000 mm3, neutrophils >/= 1500 mm3, platelets >/= 75,000, CEA
< 300 ng/mL
- Hepatic: Serum bilirubin </= 2.0 mg/dL, ALT < 2.5 x IULN
- Cardiovascular: Patients with LVEF >/= 40% by required MUGA/2D-ECHO study.
- Pulmonary: Patients with FEV1 >/= 60% by required Pulmonary Function Tests
- Other: Patients agreeing to use a medically effective method of contraception during
and for a period of 3 months after the treatment period. A pregnancy test will be
preformed on each premenopausal female of childbearing potential immediately prior to
entry into the study. Patients able to understand and give written informed consent.
Patients with a significant concurrent medical condition that could affect the
patient's ability to tolerate or complete the study.