Expired Study
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Newport Beach, California 92658


Purpose:

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.


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.


NCT ID:

NCT00041652


Primary Contact:

Study Director
Terence Rugg, MD
Immunomedics, Inc.


Backup Contact:

N/A


Location Contact:

Newport Beach, California 92658
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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