Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer

Phase 1

Withdrawn

• Conditions: Colorectal Cancer; Esophageal Cancer; Gastric Cancer; Pancreatic Cancer

• Registration Number: NCT00025532
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

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.

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2001-10-11
• Study First Submitted QC: 2003-11-20
• Study First Posted: 2003-11-21
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-13
• Last Update Posted: 2012-09-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

UCSF Cancer Center and Cancer Research Institute; 🇺🇸 San Francisco, California, United States