Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer
|ClinicalTrials.gov Identifier: NCT00025532|
Recruitment Status : Withdrawn
First Posted : November 21, 2003
Last Update Posted : September 14, 2012
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 or disease||Intervention/treatment||Phase|
|Colorectal Cancer Esophageal Cancer Gastric Cancer Pancreatic Cancer||Other: iodine I 131 monoclonal antibody CC49-deltaCH2||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Official Title:||A Pre-Phase I Biodistribution Study Of hCC^CH2 Labeled With 131 Iodine In Patients With Gastrointestinal Adenocarcinomas|
|Study Start Date :||April 2001|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00025532
|United States, California|
|UCSF Cancer Center and Cancer Research Institute|
|San Francisco, California, United States, 94143-0128|
|Study Chair:||Margaret A. Tempero, MD||University of California, San Francisco|