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Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer

This study has been completed.

Sponsors and Collaborators: UCSF Helen Diller Family Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025532
  Purpose

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for gastrointestinal cancer.

PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have gastrointestinal cancer.


Condition Intervention Phase
Colorectal Cancer
Esophageal Cancer
Gastric Cancer
Pancreatic Cancer
Drug: iodine I 131 monoclonal antibody CC49-deltaCH2
Phase I

Genetics Home Reference related topics:   Colorectal Cancer  

MedlinePlus related topics:   Cancer   Colorectal Cancer   Esophageal Cancer   Esophagus Disorders   Pancreatic Cancer   Stomach Cancer  

ChemIDplus related topics:   Iodine   Sodium iodide I 131   Pancrelipase   Ultrase   Cadexomer iodine  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Pre-Phase I Biodistribution Study Of hCC^CH2 Labeled With 131 Iodine In Patients With Gastrointestinal Adenocarcinomas

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   April 2001

Detailed Description:

OBJECTIVES: I. Determine the biodistribution and biokinetics of iodine I 131-labeled monoclonal antibody CC49-delta CH2 in patients with gastrointestinal adenocarcinoma. II. Determine the human anti-human monoclonal antibody response in patients treated with this drug.

OUTLINE: Patients receive iodine I 131-labeled monoclonal antibody CC49-delta CH2 (131I MOAB CC49-delta CH2) IV over 5-10 minutes on day 0. Patients also receive unlabeled monoclonal antibody CC49-delta CH2 IV over 5 minutes followed by 131I MOAB CC49-delta CH2 IV over 5-10 minutes on day 28. Patients are followed weekly for 4 months and then every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1 year.

  Eligibility
Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the esophagus, stomach, pancreas, colon, or rectum More than 30% positively immunoreactive to monoclonal antibody CC49 in the metastatic or primary lesion OR TAG-72 antigen serum level greater than 15 Measurable or evaluable unresectable or metastatic disease by CT scan

PATIENT CHARACTERISTICS: Age: 19 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 150,000/mm3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin less than 2.0 mg/dL ALT and AST less than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present) PTT less than 37.0 seconds INR less than 2.0 Renal: Creatinine less than 2.0 mg/dL Other: No known allergy to murine immunoglobulin No iodine allergy No concurrent illness that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Must be ambulatory and able to comply with study schedule

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior murine immunoglobulin Chemotherapy: Prior or concurrent chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: See Disease Characteristics

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025532

Locations
United States, California
UCSF Cancer Center and Cancer Research Institute    
      San Francisco, California, United States, 94143-0128

Sponsors and Collaborators
UCSF Helen Diller Family Comprehensive Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Margaret A. Tempero, MD     UCSF Helen Diller Family Comprehensive Cancer Center    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068971, UCSF-H11156-18101-02, UCSF-00455, NCI-T97-0054
First Received:   October 11, 2001
Last Updated:   May 23, 2008
ClinicalTrials.gov Identifier:   NCT00025532
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III colon cancer  
stage IV colon cancer  
stage III gastric cancer  
stage IV gastric cancer  
recurrent gastric cancer  
stage III pancreatic cancer  
recurrent pancreatic cancer  
stage III rectal cancer  
stage IV rectal cancer  
recurrent colon cancer  
recurrent rectal cancer
stage III esophageal cancer
stage IV esophageal cancer
recurrent esophageal cancer
adenocarcinoma of the stomach
adenocarcinoma of the esophagus
adenocarcinoma of the colon
adenocarcinoma of the rectum
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Study placed in the following topic categories:
Gastrointestinal Diseases
Pancreatic Neoplasms
Esophageal Neoplasms
Colonic Diseases
Pancrelipase
Rectal Diseases
Antibodies, Monoclonal
Stomach Diseases
Stomach Neoplasms
Iodine
Esophageal neoplasm
Rectal cancer
Endocrine Gland Neoplasms
Digestive System Neoplasms
Esophageal disorder
Stomach cancer
Intestinal Diseases
Intestinal Neoplasms
Recurrence
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Digestive System Diseases
Neoplasms by Site
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Endocrine System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008




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