Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 19 and over NCI UCSF-H11156-18101-02 UCSF-00455, NCI-T97-0054, NCT00025532, T97-0054

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.

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

UCSF Helen Diller Family Comprehensive Cancer Center

Margaret Tempero, MD, Protocol chair		Ph: 415-885-3846; 800-888-8664 Email: mtempero@medicine.ucsf.edu

Registry Information
Official Title		A Pre-Phase I Biodistribution Study Of hCC^CH2 labeled With 131 Iodine In Patients With Gastrointestinal Adenocarcinomas
Trial Start Date		2001-04-16
Registered in ClinicalTrials.gov		NCT00025532
Date Submitted to PDQ		2001-08-17
Information Last Verified		2007-04-20
NCI Grant/Contract Number		CA82103