Clinical trialPhase 1Withdrawn
Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer
A Pre-Phase I Biodistribution Study Of hCC^CH2 Labeled With 131 Iodine In Patients With Gastrointestinal Adenocarcinomas
- Outcome
- Stopped early
- Phase
- Phase 1
- Status
- Withdrawn
- Study type
- Interventional
- Start
- April 2001
- Enrollment
- 0 participants
- Sites
- 1
- Sponsor
- Other
- Results posted
- No
- Last update
- 14 September 2012
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Source text
Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.