Back to resultsBispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
enzyme-linked immunosorbent assay
pharmacological study
whole-body scintigraphy
iodine I 131-labeled anti-CEA/anti-HSG bispecific monoclonal antibody TF2
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal cancer
- Radiological documentation of disease is preferred, but not required
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%
- Life expectancy ≥ 3 months
- WBC ≥ 3,000/mm³
- Neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Serum creatinine normal
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST/ALT < 2 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for 1 month after completion of study therapy
- No medical conditions that might prevent full participation in protocol-required testing or follow-up
- No institutionalized patients (e.g., in prisons or mental health institutions)
PRIOR CONCURRENT THERAPY:
- No concurrent chemotherapy or treatments that would compromise the safety and efficacy of protocol assessments
Sites / Locations
- Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterRecruiting
Outcomes
Primary Outcome Measures
Pharmacokinetics
Tissue distribution
Secondary Outcome Measures
Full Information
NCT ID
NCT00895323
First Posted
May 7, 2009
Last Updated
September 16, 2013
Sponsor
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
1. Study Identification
Unique Protocol Identification Number
NCT00895323
Brief Title
Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
Official Title
Phase I Study of Preoperative Detection of Colorectal Carcinoma With Bispecific Antibody Pretargeting
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Diagnostic procedures, such as radionuclide imaging using bispecific antibody, may help find colorectal cancer cells and learn the extent of disease.
PURPOSE: This phase I trial is studying how well a bispecific antibody works in finding tumor cells in patients with colorectal cancer.
Detailed Description
OBJECTIVES:
Assess the pharmacokinetics and tissue distribution of anti-CEA x anti-HSG bispecific monoclonal antibody TF2 in patients with colorectal cancer.
OUTLINE: This is a multicenter study.
Patients receive iodine I 131-labeled anti-CEA x anti-HSG bispecific monoclonal antibody TF2 (^131I-TF2) IV over 10-20 minutes on day 1. Patients also undergo whole-body external scintigraphy at various times during the study.
Blood samples are collected at baseline and periodically after ^131I-TF2 infusion for pharmacokinetic studies and ^131I-TF2 biodistribution by ELISA and radioactivity measurements.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
9 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
enzyme-linked immunosorbent assay
Intervention Type
Other
Intervention Name(s)
pharmacological study
Intervention Type
Procedure
Intervention Name(s)
whole-body scintigraphy
Intervention Type
Radiation
Intervention Name(s)
iodine I 131-labeled anti-CEA/anti-HSG bispecific monoclonal antibody TF2
Primary Outcome Measure Information:
Title
Pharmacokinetics
Title
Tissue distribution
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal cancer
Radiological documentation of disease is preferred, but not required
PATIENT CHARACTERISTICS:
Karnofsky performance status 70-100%
Life expectancy ≥ 3 months
WBC ≥ 3,000/mm³
Neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Serum creatinine normal
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST/ALT < 2 times ULN
Not pregnant or nursing
Fertile patients must use effective contraception during and for 1 month after completion of study therapy
No medical conditions that might prevent full participation in protocol-required testing or follow-up
No institutionalized patients (e.g., in prisons or mental health institutions)
PRIOR CONCURRENT THERAPY:
No concurrent chemotherapy or treatments that would compromise the safety and efficacy of protocol assessments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aiwu R. He, MD
Organizational Affiliation
Lombardi Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Lombardi Comprehensive Cancer Center
Phone
202-444-0381
12. IPD Sharing Statement
Learn more about this trial
Bispecific Antibody in Finding Tumor Cells in Patients With Colorectal Cancer
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