Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer

Gilead Sciences

Status and phase

Completed

Phase 2

Phase 1

Conditions

Colorectal Carcinoma

Breast Cancer

Colon Cancer

Breast Neoplasms

Colorectal Neoplasms

Rectal Cancer

Colorectal Cancer

Treatments

Drug: hMN14 (labetuzumab)

Study type

Interventional

Funder types

Industry

Identifiers

IM-T-hMN14-04

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Disease Characteristics:

Histologic or cytologic diagnosis or either, colonic, rectal, or breast carcinoma
Measurable lesion diagnosed by CT scan
Recurrent/metastatic disease considered surgically unresectable.

Prior/Concurrent Therapy:

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 treatment)
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.