NCT00647153

Brief Summary

RATIONALE: Diagnostic procedures, such as immunoscintigraphy, using a radiolabeled monoclonal antibody may help find and diagnose colorectal cancer. PURPOSE: This clinical trial is studying how well immunoscintigraphy using a radiolabeled monoclonal antibody works in finding tumor cells in patients with colorectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_1 colorectal-cancer

Timeline
Completed

Started May 2006

Longer than P75 for phase_1 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

6.4 years

First QC Date

March 28, 2008

Last Update Submit

November 2, 2017

Conditions

Colorectal Cancer

Keywords

stage I colon cancerstage II colon cancerstage III colon cancerstage IV colon cancerstage I rectal cancerstage II rectal cancerstage III rectal cancerstage IV rectal cancer

Outcome Measures

Primary Outcomes (1)

  • Tumor targeting properties of iodine I 123 anti-CEA recombinant diabody T84.66

    Day 2 post infusion

Secondary Outcomes (3)

  • Clinical pharmacokinetics of iodine I 123 anti-CEA recombinant diabody T84.66

    Day 2 post infusion

  • Immunogenicity properties of iodine I 123 anti-CEA recombinant diabody T84.66

    6 months post infusion

  • Safety of iodine I 123 anti-CEA recombinant diabody T84.66

    6 months post infusion

Study Arms (1)

Radiation: iodine I 123 anti-CEA recombinant diabody T84.66

EXPERIMENTAL
Other: pharmacological studyProcedure: single photon emission computed tomographyRadiation: iodine I 123 anti-CEA recombinant diabody T84.66

Interventions

pharmacological studyOTHER

Pre-infusion and 30 min., 1h,2h, and 3-4h post start of infusion. Day 1 and 2 post infusion.

Radiation: iodine I 123 anti-CEA recombinant diabody T84.66
single photon emission computed tomographyPROCEDURE

One day post infusion

Radiation: iodine I 123 anti-CEA recombinant diabody T84.66
iodine I 123 anti-CEA recombinant diabody T84.66RADIATION

10mCi/mg

Radiation: iodine I 123 anti-CEA recombinant diabody T84.66

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed colorectal cancer * Stage I-IV disease PATIENT CHARACTERISTICS: * Serum creatinine \< 2.0 mg/dL * Total bilirubin \< 2.0 mg/dL * Hemoglobin \> 9.0 g/dL * cT84.66 antibody negative (if previously treated with mouse or chimeric immunoglobulins) * Not pregnant * No condition that, in the opinion of the investigator, would preclude study compliance * No known allergy to iodine * No known history of HIV, hepatitis B, or hepatitis C PRIOR CONCURRENT THERAPY: * No concurrent steroids

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

Sponsors & Collaborators

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jeffrey Y. Wong, MD

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2008

First Posted

March 31, 2008

Study Start

May 1, 2006

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

US(1)