Safety Study of hMN14 to Treat Either Colorectal or Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-02-29

Study Completion Date

2003-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Cancer Colon Cancer Rectal Cancer Colorectal Neoplasms Colorectal Carcinoma Breast Cancer Breast Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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hMN14 (labetuzumab)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No