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A Pre-Phase I Biodistribution Study Of hCC^CH2 Labeled With 131 Iodine In Patients With Gastrointestinal Adenocarcinomas

Phase 1
19 Years
Not Enrolling
Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Pancreatic Cancer

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Trial Information

A Pre-Phase I Biodistribution Study Of hCC^CH2 Labeled With 131 Iodine In Patients With Gastrointestinal Adenocarcinomas

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

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

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

Inclusion 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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Margaret A. Tempero, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Federal Government

Study ID:




Start Date:

April 2001

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Esophageal Cancer
  • Gastric Cancer
  • Pancreatic Cancer
  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colorectal Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Gastrointestinal Neoplasms



UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128