NCT00025532

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2001

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

November 21, 2003

Completed
Last Updated

September 14, 2012

Status Verified

September 1, 2012

First QC Date

October 11, 2001

Last Update Submit

September 13, 2012

Conditions

Colorectal CancerEsophageal CancerGastric CancerPancreatic Cancer

Keywords

stage III colon cancerstage IV colon cancerstage III gastric cancerstage IV gastric cancerrecurrent gastric cancerstage III pancreatic cancerrecurrent pancreatic cancerstage III rectal cancerstage IV rectal cancerrecurrent colon cancerrecurrent rectal cancerstage III esophageal cancerstage IV esophageal cancerrecurrent esophageal canceradenocarcinoma of the stomachadenocarcinoma of the esophagusadenocarcinoma of the colonadenocarcinoma of the rectumadenocarcinoma of the pancreasstage IV pancreatic cancer

Interventions

iodine I 131 monoclonal antibody CC49-deltaCH2OTHER

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsEsophageal NeoplasmsStomach NeoplasmsPancreatic NeoplasmsColonic NeoplasmsRectal NeoplasmsAdenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesHead and Neck NeoplasmsEsophageal DiseasesStomach DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Margaret A. Tempero, MD

    University of California, San Francisco

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 11, 2001

First Posted

November 21, 2003

Study Start

April 1, 2001

Last Updated

September 14, 2012

Record last verified: 2012-09

Locations

US(1)