A Phase I/II Clinical Trial of Immunotherapy With Humanized MN-14 IgG in Recurrent, Metastatic, Unresectable Colorectal and Breast Carcinomas
18 Years
N/A
Both
Colorectal Cancer, Colon Cancer, Rectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Breast Cancer, Breast Neoplasms
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 |
