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A Phase I/II Clinical Trial of Immunotherapy With Humanized MN-14 IgG in Recurrent, Metastatic, Unresectable Colorectal and Breast Carcinomas


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Breast Cancer, Breast Neoplasms

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Trial Information

A Phase I/II Clinical Trial of Immunotherapy With Humanized MN-14 IgG in Recurrent, Metastatic, Unresectable Colorectal and Breast Carcinomas


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
- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Terence Rugg, MD

Investigator Role:

Study Director

Investigator Affiliation:

Immunomedics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

IM-T-hMN14-04

NCT ID:

NCT00041652

Start Date:

February 2000

Completion Date:

June 2003

Related Keywords:

  • Colorectal Cancer
  • Colon Cancer
  • Rectal Cancer
  • Colorectal Neoplasms
  • Colorectal Carcinoma
  • Breast Cancer
  • Breast Neoplasms
  • Colorectal Cancer
  • Colon Cancer
  • Rectal Cancer
  • Colorectal Neoplasms
  • Colorectal Carcinoma
  • Breast Cancer
  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms
  • Carcinoma
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms

Name

Location
Hoag Cancer Center Newport Beach, California  92658