- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00025532
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
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.
Study Overview
Status
Intervention / Treatment
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 Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- adenocarcinoma of the rectum
- stage IV rectal cancer
- stage IV colon cancer
- adenocarcinoma of the colon
- recurrent colon cancer
- recurrent rectal cancer
- recurrent pancreatic cancer
- adenocarcinoma of the pancreas
- stage III colon cancer
- stage IV pancreatic cancer
- stage IV gastric cancer
- recurrent gastric cancer
- stage III gastric cancer
- stage III esophageal cancer
- adenocarcinoma of the stomach
- adenocarcinoma of the esophagus
- recurrent esophageal cancer
- stage III rectal cancer
- stage III pancreatic cancer
- stage IV esophageal cancer
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Head and Neck Neoplasms
- Esophageal Diseases
- Pancreatic Diseases
- Stomach Neoplasms
- Adenocarcinoma
- Pancreatic Neoplasms
- Esophageal Neoplasms
- Physiological Effects of Drugs
- Immunologic Factors
- Antibodies
- Antibodies, Monoclonal
Other Study ID Numbers
- CDR0000068971
- UCSF-H11156-18101-02
- UCSF-00455
- NCI-T97-0054
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